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Cook, Inc.

United States·US-MF-000003180

Last updated September 17, 2026

Information

Country: United States
Address: 750 Daniels way, Bloomington, United States
Website: www.cookmedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 812 339 2235
PRRC Contact: Matt Graf
EUDAMED SRN: US-MF-000003180
FDA FEI Number: 3012766489
DUNS Number: —

Catalogue (218)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Atb Advanced Pta Dilatation Catheter	K063252	FDA 510(k)	Class II	Active
Lunderquist Extra Stiff Double Curved Exchange Wire Guide	K042611	FDA 510(k)	Class II	Active
Coating For Wire Guide	K880722	FDA 510(k)	Class II	Active
Prostate Biopsy Needle	K770122	FDA 510(k)	Class II	Active
Zilver 518 Biliary Stent	K042518	FDA 510(k)	Class II	Active
Quick-Care Biopsy Needle	K973565	FDA 510(k)	Class II	Active
Cook Coda Balloon Catheter	K032869	FDA 510(k)	Class II	Active
Reigel Tunneling Device	K962761	FDA 510(k)	Class I	Active
Ciaglia Blue Dolphin (tm) Balloon Percutaneous Tracheostomy Introducer	K072148	FDA 510(k)	Class II	Active
Wholey Occlusion Balloon Catheter	K772011	FDA 510(k)	Class II	Active
Esophageal Z-Stent	K914029	FDA 510(k)	Class II	Active
Hilal Embolization Microcoil(tm)	K901337	FDA 510(k)	Class II	Active
Occlusion Balloon Catheter Model Obc	K101877	FDA 510(k)	Class II	Active
Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set	K133634	FDA 510(k)	Class II	Active
Zilver 635 Biliary Stent	K040505	FDA 510(k)	Class II	Active
Coil Positioner Set	K940189	FDA 510(k)	Class II	Active
Intraosseous Access Needle	K915409	FDA 510(k)	Class II	Active
Mri Needles	K963565	FDA 510(k)	Class II	Active
Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter	K081690	FDA 510(k)	Class II	Active
Focus (tm) Echogenic Nerve Stimulating Needle	K101728	FDA 510(k)	Class II	Active
Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray	K133597	FDA 510(k)	Class II	Active
Accemt Dg(tm) Balloon Angioplasty Cath, Modified	K924358	FDA 510(k)	Class II	Active
Mclean-Stock Percutaneous T-Tube Set	K921654	FDA 510(k)	Class II	Active
Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set	K131201	FDA 510(k)	Class II	Active
Johnson Intratracheal Oxygen Catheter Set	K870181	FDA 510(k)	Class II	Active
Spectrum Central Venous Catheter With Or Without Hydrophilic Coating	K033843	FDA 510(k)	Class II	Active
Gunther Tulip Vena Cava Filter Set	K043509	FDA 510(k)	Class II	Active
Chenoweth-Frank Radiopathological Grid	K933754	FDA 510(k)	Class II	Active
Mira-Flex 18 Microcatheter	K052841	FDA 510(k)	Class II	Active
Urological Biopsy Brush Set	K770913	FDA 510(k)	Class II	Active
Ventriclear Ii, Spectrum Ventricular Drainage Catheter, Model N-Vvdc-02-Abrm	K071640	FDA 510(k)	Class II	Active
Fanelli Biliary Stent	K010601	FDA 510(k)	Class II	Active
Mullan Ganglion Microcompression Set	K940973	FDA 510(k)	Class I	Active
Alight 16 Superselective Microwire Guide	K123707	FDA 510(k)	Class II	Active
Advance Salivary Balloon Catheter With Wire Guide	K140593	FDA 510(k)	Class II	Active
Ldob Occlusion Balloon Catheter	K002286	FDA 510(k)	Class II	Active
Accent Dg(tm) Balloon Angioplasty Catheter	K900677	FDA 510(k)	Class II	Active
Mreye Embolization Coil	K052834	FDA 510(k)	Class II	Active
Wrist Restraint For Ge9800 C.t. Tables	K923108	FDA 510(k)	Class II	Active
High Dose Rate Remote Afterloading Catheter	K923738	FDA 510(k)	Class II	Active
Modification To Atb All-Terrain Balloon Pta Dilatation Catheter	K023504	FDA 510(k)	Class II	Active
Cook Five Lumen Central Venous Catheter	K032274	FDA 510(k)	Class II	Active
Scan Band	K923110	FDA 510(k)	Class II	Active
Embolization Coil System	K992121	FDA 510(k)	Class II	Active
Melker Cuffed Emergency Cricothyrotomy Catheter	K010016	FDA 510(k)	Class II	Active
Miraflex High Flow Microcatheter	K080737	FDA 510(k)	Class II	Active
Body Band Restraint Strap Set	K923107	FDA 510(k)	Class II	Active
Disposable Introsseous Infusion Needles	K913258	FDA 510(k)	Class II	Active
Vascular Catheter & Wire Guides W/Medi-Coat(tm)	K914856	FDA 510(k)	Class II	Active
Arterial Embolization Device (krd)	K940982	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 12, 2021	Z-0387-2022	—	terminated	Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Nov 12, 2021	Z-0388-2022	—	terminated	Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Oct 13, 2021	Z-0414-2022	—	open, classified	Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Oct 8, 2021	Z-0223-2022	—	terminated	Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Oct 8, 2021	Z-0222-2022	—	terminated	Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Sep 28, 2021	Z-0185-2022	—	terminated	Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Sep 28, 2021	Z-0186-2022	—	terminated	Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Jan 4, 2021	Z-0960-2021	—	terminated	Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Nov 24, 2020	Z-0592-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0600-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0605-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0595-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0599-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0608-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0601-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0604-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0606-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0593-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0611-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0597-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0603-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0598-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0596-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0602-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0607-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0609-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0594-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0610-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Nov 24, 2020	Z-0591-2021	—	terminated	There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Oct 22, 2020	Z-0399-2021	—	terminated	Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Aug 31, 2020	Z-0105-2021	—	terminated	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Aug 31, 2020	Z-0106-2021	—	terminated	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Aug 11, 2020	Z-2964-2020	—	terminated	May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Jul 30, 2020	Z-2971-2020	—	terminated	Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Jun 2, 2020	Z-2546-2020	—	terminated	Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
Apr 30, 2020	Z-2203-2020	—	terminated	The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Apr 30, 2020	Z-2204-2020	—	terminated	The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Apr 15, 2020	Z-1940-2020	—	terminated	The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
Mar 6, 2020	Z-1566-2020	—	terminated	The printed expiration dates are incorrect.
Mar 6, 2020	Z-1565-2020	—	terminated	The printed expiration dates are incorrect.
Jan 16, 2020	Z-1355-2020	—	terminated	The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.
Dec 27, 2019	Z-0815-2020	—	terminated	Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
Nov 8, 2019	Z-0590-2020	—	terminated	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Nov 8, 2019	Z-0588-2020	—	terminated	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Nov 8, 2019	Z-0587-2020	—	terminated	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Nov 8, 2019	Z-0589-2020	—	terminated	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Oct 21, 2019	Z-0481-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0449-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0472-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0454-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0429-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0447-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0469-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0455-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0423-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0477-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0483-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0465-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0421-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0445-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0486-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0485-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0430-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0435-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0427-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0478-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0480-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0468-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0448-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0479-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0473-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0484-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0474-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0487-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0438-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0475-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0453-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0425-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0434-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0489-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0422-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0458-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0426-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0450-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0460-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0466-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0476-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0490-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0436-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0457-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0431-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0452-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0471-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0440-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0437-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0464-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0470-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0444-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0428-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Z-0467-2020	—	terminated	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.