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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Turbo-Flo Picc	K041849	FDA 510(k)	Class II	Active
Flexible Myocardial Biopsy Forceps	K883723	FDA 510(k)	Class II	Active
Wittich Nitinol Stone Basket	K902944	FDA 510(k)	Class II	Active
Advance 18lp Low Profile Pta Balloon Dilatation Catheter	K130293	FDA 510(k)	Class II	Active
Slip-Coat(tm) Catheters	K882796	FDA 510(k)	Class II	Active
Greco-Harvey Surfactant Bonded Catheter For Cardio	K851241	FDA 510(k)	Class II	Active
Vrac High Dose Rate (hdr) Remote Afterloading Catheter	K981886	FDA 510(k)	Class II	Active
Modified Cope Suture Anchor	K873606	FDA 510(k)	Class II	Active
Gianturco-Helfrich Hernis Mesh	K931936	FDA 510(k)	Class II	Active
Detach 18 And Detach 11, Neurological Embolization Coil System	K000651	FDA 510(k)	Class II	Active
Roadrunner(tm) Wire Guide, Modification	K920891	FDA 510(k)	Class II	Active
Introdeuce Double Lumen Introducer	K001985	FDA 510(k)	Class II	Active
Coverd Gianturco-Rosch Esophageal Z-Stent	K945201	FDA 510(k)	Class II	Active
Gunther Tulip Vena Cava Filter	K072240	FDA 510(k)	Class II	Active
Turbo-Ject Peripherally Inserted Central Venous Catheter (picc)	K072625	FDA 510(k)	Class II	Active
Strategy Coronary Wire Guide	K983771	FDA 510(k)	Class II	Active
Modification To Uldall Double Lumen Hemodialysis Catheter Set And Tray	K982333	FDA 510(k)	Class II	Active
Dotter Balloon Transluminal Angio. Catheter (poly)	K870215	FDA 510(k)	Class II	Active
Laparoscopic Access Sheath Set	K903124	FDA 510(k)	Class II	Active
Adult Chin Strap For Ct Tables	K923109	FDA 510(k)	Class II	Active
Gianturco-Rosch Biliary Z Stent	K921191	FDA 510(k)	Class II	Active
Greco-Harvey Surfactant Bonded Catheter For Gastro	K851242	FDA 510(k)	Class II	Active
Cook Mreye Embolization Coils	K090624	FDA 510(k)	Class II	Active
Advance 18lp Pta Dilatation Catheter	K073378	FDA 510(k)	Class II	Active
Melker Emergency Cricothyrotomy Catheter Set	K013916	FDA 510(k)	Class II	Active
Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple, Prefix C-Ptbs	K093469	FDA 510(k)	Class II	Active
Welter Snare Retriever	K920823	FDA 510(k)	Class II	Active
Urethane Picc Line Model Upics-	K992198	FDA 510(k)	Class II	Active
Gianturco-Wallace Tracheobronchial Z Stent	K891411	FDA 510(k)	Class II	Active
Greco-Harvey Surfactant Bonded Cath For Anesthesio	K851244	FDA 510(k)	Class II	Active
Gunther Tulip Vena Cava Mreye Filter Set	K000855	FDA 510(k)	Class II	Active
Grac High Dose Rate (hdr) Remote Afterloading Catheter	K990753	FDA 510(k)	Class II	Active
Flipper Detachable Embolization Coil	K993455	FDA 510(k)	Class II	Active
Advance 34lp Low Profile Pta Balloon Dilatation Catheter	K132020	FDA 510(k)	Class II	Active
Modification To Zilver 635 Biliary Stent	K080037	FDA 510(k)	Class II	Active
Cook Pressure Monitoring Catheter	K002254	FDA 510(k)	Class II	Active
Envy Guiding Catheter	K974774	FDA 510(k)	Class II	Active
Catheter, Gruntzig, Ballon	K770522	FDA 510(k)	Class II	Active
Approach Hydro St Wire Guide, Model Hmw	K091385	FDA 510(k)	Class II	Active
Formula 418 Biliary Stent	K051785	FDA 510(k)	Class II	Active
Rowe Dual-Check Valve	K983217	FDA 510(k)	Class II	Active
Double Lumen Urethane Picc Line, Model Upicds-	K010034	FDA 510(k)	Class II	Active
Cook Formula 418 Biliary Stent System	K052539	FDA 510(k)	Class II	Active
Cook (r) Vein Graft Ring Markers	K864101	FDA 510(k)	Class II	Active
Advance 14rx Rapid Exchange Pta Balloon Catheter	K090822	FDA 510(k)	Class II	Active
Cook Microwire Wire Guide	K070410	FDA 510(k)	Class II	Active
Spectrum Five Lumen Central Venous Catheter Set, Model C-Uqlm10.0-Abrm	K060174	FDA 510(k)	Class II	Active
Cardiac Output Measure System	K831185	FDA 510(k)	Class II	Active
Liver Tamponade Balloon	K010450	FDA 510(k)	Class II	Active
Turbo-Ject Peripherally Inserted Central Venous Catheter (picc)	K111244	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.