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cook incorporated

24 recalls on record

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Cook Incorporated — 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-VC

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.

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Cook Incorporated — 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,

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.

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Cook Incorporated — 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

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.

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Cook Incorporated — 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.

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Cook Incorporated — 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.

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Cook Incorporated — 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-UN

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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.

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Cook Incorporated — 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

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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 G

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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.

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Cook Incorporated — 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.

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Cook Incorporated — 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-N

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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.

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Cook Incorporated — 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, Ord

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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.

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Cook Incorporated — 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.

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Cook Incorporated — 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

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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-CUST

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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.

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Cook Incorporated — 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.

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Cook Incorporated — 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

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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Cook Incorporated — 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

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.

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Cook Incorporated — R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagno

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.

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Cook Incorporated — 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-1

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.