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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 1 of 5

Device	Model / Reference	Registries	Class	Status
Pta Balloon Catheter	K980390	FDA 510(k)	Class II	Active
Cook Spectrum	G10039	FDA UDI	Class II	Active
Franseen	G01269	FDA UDI	Class I	Active
Beacon Tip Torcon NB	G11478	FDA UDI	Class II	Active
Cook	G24699	FDA UDI	Class II	Active
Amplatz	G04167	FDA UDI	Class II	Unknown
Flexor	G09908	FDA UDI	Class II	Active
Advance	G34293	FDA UDI	Class II	Unknown
Royal Flush	G05060	FDA UDI	Class II	Active
Flexor	G47700	FDA UDI	Class II	Active
Nester	G52765	FDA UDI	Class II	Active
Universa	G49864	FDA UDI	Class II	Active
Cook	G14100	FDA UDI	Class I	Active
Cook	G00467	FDA UDI	Class II	Active
Advance	G26879	FDA UDI	Class II	Active
Cook	G06249	FDA UDI	Class II	Active
Cook	G14050	FDA UDI	Class II	Active
Formula 418	G56607	FDA UDI	Class III	Active
Coons	G12196	FDA UDI	Class II	Active
Torcon NB	G08000	FDA UDI	Class II	Active
Advance	G30884	FDA UDI	Class II	Active
Cook	G17797	FDA UDI	Class II	Active
Fusion	G48277	FDA UDI	Class II	Active
Cook Spectrum	G36221	FDA UDI	Class II	Active
Universa	G53702	FDA UDI	Class II	Active
Universa	G53710	FDA UDI	Class II	Active
Cook	G58413	FDA UDI	Class II	Active
Cantata	G54534	FDA UDI	Class II	Active
Zilver 635 Biliary Stent	K051124	FDA 510(k)	Class II	Active
Flipper Detachable Embolization Coils	K063619	FDA 510(k)	Class II	Active
Hysteroscopy Sheath Set	K903146	FDA 510(k)	Class II	Active
Roadrunner Wire Guide	K901899	FDA 510(k)	Class II	Active
Modification To:zilver 518 Biliary Stent	K050698	FDA 510(k)	Class II	Active
Atb All-Terrain Balloon Pta Dilatation Catheter	K031766	FDA 510(k)	Class II	Active
Advance 35lp Low Profile Pta Balloon Dilatation Catheter	K091527	FDA 510(k)	Class II	Active
Microferret Catheter	K961668	FDA 510(k)	Class II	Active
Head Restraint For Ct Tables	K923114	FDA 510(k)	Class II	Active
Modification To: Zilver 635 Biliary Stent	K043481	FDA 510(k)	Class II	Active
Cantata(r) 2.9 Microcatheter	K131772	FDA 510(k)	Class II	Active
Connex Gastrointestinal Suture Anchor, Model Gias	K090133	FDA 510(k)	Class II	Active
Envy Guiding Catheter	K990726	FDA 510(k)	Class II	Active
Magnet Retrieval Catheter	K900852	FDA 510(k)	Class II	Active
Zilver 518 Biliary Stent	K033348	FDA 510(k)	Class II	Active
Blade Septostomy Catheter	K801031	FDA 510(k)	Class II	Active
Rutner Universal Wedge Catheter	K760858	FDA 510(k)	Class II	Active
Cook-Gianturco Biliary Z Stent	K882610	FDA 510(k)	Class II	Active
Cook Stereotaxic Guide	K900200	FDA 510(k)	Class II	Active
Murdoch Laparoscope Lens Cleaner	K941092	FDA 510(k)	Class II	Active
Arndt Pediatric Endobronchial Blocker	K002288	FDA 510(k)	Class II	Active
Atb Advance Pta Dilatation Catheter	K052036	FDA 510(k)	Class II	Active

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Importers

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Authorities

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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.