Cook Incorporated
Ellettsville, IN, US
Cook Incorporated appears in FDA device records in Ellettsville, IN. FDA records list 279 510(k) clearances between and , 100 PMA records and 4 registered establishments. As of , FDA records show 674 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Cook Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cook Urological, Inc.510(k), recall
- Cook, Inc.PMA, recall
- Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYNrecall
- Vance Products Incorporatedrecall
510(k) clearance history
Showing 50 of 279FDA records hold 279 510(k) clearances for Cook Incorporated between 1986 and 2024. The busiest year on record is 2018, with 59. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 10 |
| 1993 | 10 |
| 1994 | 12 |
| 1995 | 7 |
| 1996 | 15 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 8 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 13 |
| 2016 | 18 |
| 2017 | 40 |
| 2018 | 59 |
| 2019 | 24 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233177 | Nest VT Vitrification Device | MQK | Substantially Equivalent | |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | MMX | Substantially Equivalent | |
| K223098 | Bakri Essential Postpartum Balloon | OQY | Substantially Equivalent | |
| K210734 | Endovascular Dilator and Sets | DRE | Substantially Equivalent | |
| K203670 | Extra Large Check-Flo Introducer | DYB | Substantially Equivalent | |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | LJE | Unknown | |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | LJE | Substantially Equivalent | |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | JOH | Substantially Equivalent | |
| K191163 | Lumax Guiding Catheter | DQY | Substantially Equivalent | |
| K190084 | McLean-Ring Enteral Feeding Tube Set | KNT | Substantially Equivalent | |
| K183323 | UPJ Occlusion Balloon Catheter | EYB | Unknown | |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | DQX | Substantially Equivalent | |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | LJE | Unknown | |
| K191485 | Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | KGC | Unknown | |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | EYB | Unknown | |
| K182403 | Peel-Away Introducer | FED | Substantially Equivalent | |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | MQF | Substantially Equivalent | |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | LJE | Unknown | |
| K182252 | Cook Unimpregnated Central Venous Catheter | FOZ | Substantially Equivalent | |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | |
| K182071 | Multi-Sideport Catheter Infusion Set | KRA | Substantially Equivalent | |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | FAD | Unknown | |
| K182399 | Park Blade Septostomy Catheter | DXF | Substantially Equivalent | |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | LKF | Substantially Equivalent | |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | LJE | Unknown | |
| K181722 | Polyethylene Catheter | DQO | Substantially Equivalent | |
| K181353 | Lunderquist® Fixed Core Wire Guide | DQX | Substantially Equivalent | |
| K181097 | Cook Cystostomy Catheter Set | KOB | Unknown | |
| K183467 | Roadrunner Extra Support Wire Guide | DQX | Substantially Equivalent | |
| K182709 | One-Step Suprapubic Introducer | KOB | Substantially Equivalent | |
| K183036 | Dilator Sets | DRE | Substantially Equivalent | |
| K180830 | Reuter Tip Deflecting Wire Guide | DQX | Substantially Equivalent | |
| K180846 | Arterial Pressure Monitoring Set/Tray | DQO | Unknown | |
| DEN170055 | Retrograde Intubation Set | QCX | Unknown | |
| K180792 | Arterial Pressure Monitoring Set/Tray | DQO | Substantially Equivalent | |
| K180557 | Greene Renal Transplant Stent Set | FAD | Substantially Equivalent | |
| K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | MMX | Substantially Equivalent | |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | KOB | Unknown | |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | LKF | Substantially Equivalent | |
| K180291 | Cook Silicone Balloon HSG Catheter | LKF | Substantially Equivalent | |
| K180286 | Polyethylene Catheter | DQO | Substantially Equivalent | |
| K180302 | Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter | MQF | Substantially Equivalent | |
| K180054 | Royal Flush Plus High-Flow Catheter | DQO | Substantially Equivalent | |
| K180216 | Seidmon Antegrade AQ Stent Set | FAD | Substantially Equivalent | |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | FAD | Substantially Equivalent | |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | EYB | Substantially Equivalent | |
| K180053 | Sof-Flex Ureteral Stent Set | FAD | Substantially Equivalent | |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | EZL | Substantially Equivalent | |
| K181713 | Ultraxx Nephrostomy Balloon Catheter Set | LJE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000393132 | 1000393132 | COOK INCORPORATED | 6300 N. MATTHEWS DR., ELLETTSVILLE, IN 47429 US | 2026 | and 68 more, listed in full below |
| 1820334 | 1820334 | Cook Incorporated | 750 DANIELS WAY, Bloomington, IN 47404 US | 2026 | and 192 more, listed in full below |
| 1825146 | 1825146 | Cook Incorporated | 1100 W Morgan St, Spencer, IN 47460 US | 2026 | and 90 more, listed in full below |
| 3011050534 | 3011050534 | Cook Incorporated | 300 E Elm St, Canton, IL 61520 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- EYIAdaptor, Ureteral Catheter
- EXGBag, Urine Collecting, Ureterostomy
- FCGBiopsy Needle
- FAXBougie, Urological
- EOQBronchoscope (Flexible Or Rigid)
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXECatheter, Embolectomy
- DQOCatheter, Intravascular, Diagnostic
- FEWCatheter, Malecot
- DQYCatheter, Percutaneous
- EZLCatheter, Retention Type, Balloon
- DXFCatheter, Septostomy
- EYBCatheter, Ureteral, Gastro-Urology
- EXBCollector, Ostomy
- BZAConnector, Airway (Extension)
- EYKConnector, Ureteral Catheter
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FAJCystoscope And Accessories, Flexible/Rigid
- DWZDevice, Biopsy, Endomyocardial
- FENDevice, Cystometric, Hydraulic
- EZNDilator, Catheter, Ureteral
- FAHDilator, Urethral, Mechanical
- DREDilator, Vessel, For Percutaneous Catheterization
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FBWFiliform And Filiform Follower
- DTKFilter, Intravascular, Cardiovascular
- DPWFlowmeter, Blood, Cardiovascular
- FCLForceps, Biopsy, Non-Electric
- BWBForceps, Tube Introduction
- EYJHolder, Ureteral Catheter
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- EXDIrrigator, Ostomy
- EMFKnife, Surgical
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- DWONeedle, Biopsy, Cardiovascular
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BWCNeedle, Emergency Airway
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- BTAPump, Portable, Aspiration (Manual Or Powered)
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- FDISnare, Flexible
- FADStent, Ureteral
- EZBStylet For Catheter, Gastro-Urology
- DRBStylet, Catheter
- BSRStylet, Tracheal Tube
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- DRCTrocar
- FBQTrocar, Gastro-Urology
- BYYTube, Aspirating, Flexible, Connecting
- BTSTube, Bronchial (W/Wo Connector)
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 674| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1936-2026 | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF). | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Class I | Open, Classified | |
| Z-1935-2026 | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF). | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Class I | Open, Classified | |
| Z-1934-2026 | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience. | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Class I | Open, Classified | |
| Z-1792-2026 | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1791-2026 | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1790-2026 | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1789-2026 | COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1788-2026 | COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1787-2026 | COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1786-2026 | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1785-2026 | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1784-2026 | COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1783-2026 | COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1782-2026 | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1781-2026 | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1780-2026 | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1779-2026 | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686. | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1778-2026 | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1777-2026 | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1776-2026 | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-1775-2026 | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Class II | Open, Classified | |
| Z-0995-2026 | Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures. | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | Class II | Open, Classified | |
| Z-0994-2026 | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures. | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | Class II | Open, Classified | |
| Z-0993-2026 | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers. | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | Class II | Open, Classified | |
| Z-1902-2025 | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration). | Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain