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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Cook-Gianturco Rosch Biliary Z-Stent, Modification	K903858	FDA 510(k)	Class II	Active
H-30 Holmium Laser System	K130444	FDA 510(k)	Class II	Active
Roadrunner Uniglide Hydrophilic Wire Guide	K130766	FDA 510(k)	Class II	Active
Advance Cs Coronary Sinus Infusion Catheter	K131204	FDA 510(k)	Class II	Active
Deflecting Wire Grasper	K903707	FDA 510(k)	Class II	Active
Milne-Charkot Shott-Thur Cassette Holder	K923334	FDA 510(k)	Class II	Active
Atb Advance Pta Dilatation Catheter	K113300	FDA 510(k)	Class II	Active
Bronchial Blocker	K962167	FDA 510(k)	Class II	Active
Cantata Microcatheter	K101450	FDA 510(k)	Class II	Active
Cope Nitinol Stone Basket	K902945	FDA 510(k)	Class II	Active
Roadrunner Uniglide Hydrophilic Wire Guide	K110009	FDA 510(k)	Class II	Active
Vertefix Vertebroplasty Procedure Set	K042691	FDA 510(k)	Class II	Active
Cook Coronary Guiding Catheter	K902905	FDA 510(k)	Class II	Active
Dual Guide Introducer Catheter	K895044	FDA 510(k)	Class II	Active
Flexor Evac Aspiration Catheter	K073627	FDA 510(k)	Class II	Active
Roadrunner Rltf Guide Wire	K920824	FDA 510(k)	Class II	Active
Omega Nv(tm) Balloon Dilatation Catheter	K882052	FDA 510(k)	Class II	Active
Vascular Retrieval Forceps	K902999	FDA 510(k)	Class II	Active
Spectrum Silicone Catheter	K021557	FDA 510(k)	Class II	Active
Amplatz Heparin Coated Catheter	K832178	FDA 510(k)	Class II	Active
Crosscath Support Cathter	K093052	FDA 510(k)	Class II	Active
Ventricular Catheter Set	K962097	FDA 510(k)	Class II	Active
Modification To Cook Zilver Biliary Stent	K031821	FDA 510(k)	Class II	Active
7.0 Fr. Endobronchial Blocker	K021920	FDA 510(k)	Class II	Active
Scan Band	K923106	FDA 510(k)	Class II	Active
Atb All-Terrain Balloon Pta Dilatation Catheter	K022552	FDA 510(k)	Class II	Active
Cook Turbo-Flo Hd Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo Hd Acute Hemodialysis Catheter Set/Tray	K122091	FDA 510(k)	Class II	Active
Angio-Band	K923112	FDA 510(k)	Class II	Active
Tip Deflrcting Endobronchial Blocker	K013865	FDA 510(k)	Class II	Active
Patil Emergency Cricothyrotomy Catheter Set	K013252	FDA 510(k)	Class II	Active
Cook Cervical Ripening Balloon	K131206	FDA 510(k)	Class II	Active
Extracorporeal Membrane Oxygenation Catheter	K882771	FDA 510(k)	Class II	Active
Variable Stiffness Wire Guide	K781393	FDA 510(k)	Class II	Active
Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model Pta3	K122940	FDA 510(k)	Class II	Active
Chait Cecostomy Catheter	K982500	FDA 510(k)	Class II	Active
Flexor Radial Hydrophilic Introducer Access Set	K132592	FDA 510(k)	Class II	Active
Arm Extender For Ct Tables	K923111	FDA 510(k)	Class II	Active
Modification For Pta Balloon Catheter	K981906	FDA 510(k)	Class II	Active
Cxi Support Catheter	K072724	FDA 510(k)	Class II	Active
Abrm Catheter	K950118	FDA 510(k)	Class II	Active
Gunhter Tulip Vena Cava Mreye Filter And Retrieval Set	K032426	FDA 510(k)	Class II	Active
Enk Fiberoptic Atomizer Set	K031966	FDA 510(k)	Class II	Active
Cook Gastric Sizing Balloon Catheter	K030841	FDA 510(k)	Class II	Active
Spectrum Ventricular Catheter	K011812	FDA 510(k)	Class II	Active
Greco-Harvey Surfact Bond Cath Hyperalimentation	K851243	FDA 510(k)	Class II	Active
Cxi Support Catheter	K122796	FDA 510(k)	Class II	Active
Uldall Double Lumen Hemodialysis Catheter Set/Tray	K913468	FDA 510(k)	Class II	Active
Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set	K041044	FDA 510(k)	Class II	Active
Turbo-Ject Peripherally Inserted Central Venous Catheter (picc) Set	K132334	FDA 510(k)	Class II	Active
Cook Hysterocath(tm)	K884291	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.