Class IIOngoingZ-0993-2026
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets
Cook IncorporatedBloomington, IN, United StatesReported Dec 31, 2025 · 6 months ago
Legal News Analyst ·
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Part / Item #
- (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC: Order Number G49101
- UDI
- (01)00827002491014(17)280708(10)16683401
- Lot #
- 16683401; Reference
- Part / Item #
- (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102
- UDI
- (01)00827002491021(17)280709(10)16685978
- Lot #
- 16685978; Reference
- Part / Item #
- (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102
- UDI
- (01)00827002491021(17)280804(10)NS16724225
- Lot #
- NS16724225; Reference
- Part / Item #
- (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102
- UDI
- (01)00827002491021(17)280808(10)NS16733075
- Lot #
- NS16733075; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280619(10)16652188
- Lot #
- 16652188; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280620(10)16653824
- Lot #
- 16653824; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280626(10)16662713
- Lot #
- 16662713; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280626(10)16662715
- Lot #
- 16662715; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280701(10)16675034
- Lot #
- 16675034; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280716(10)16696277
- Lot #
- 16696277; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280721(10)16703198
- Lot #
- 16703198; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280722(10)16704975
- Lot #
- 16704975; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280724(10)16709796
- Lot #
- 16709796; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280731(10)16720389
- Lot #
- 16720389; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
- UDI
- (01)00827002562783(17)280617(10)16647121
- Lot #
- 16647121; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700
- UDI
- (01)00827002477001(17)280723(10)16707723
- Lot #
- 16707723; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700
- UDI
- (01)00827002477001(17)280806(10)16727474
- Lot #
- 16727474; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700
- UDI
- (01)00827002477001(17)280604(10)16629368
- Lot #
- 16629368; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700
- UDI
- (01)00827002477001(17)280627(10)16664784
- Lot #
- 16664784; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280714(10)NS16692276
- Lot #
- NS16692276; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280610(10)16637317
- Lot #
- 16637317; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280618(10)16649121
- Lot #
- 16649121; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280729(10)16716240
- Lot #
- 16716240; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280523(10)16614648
- Lot #
- 16614648; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279
- UDI
- (01)00827002562790(17)280611(10)16638978
- Lot #
- 16638978; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280717(10)16699013
- Lot #
- 16699013; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280527(10)16616270
- Lot #
- 16616270; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280609(10)16635801
- Lot #
- 16635801; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280620(10)16653825
- Lot #
- 16653825; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280627(10)16664786
- Lot #
- 16664786; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280702(10)16677072
- Lot #
- 16677072; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280728(10)16712983
- Lot #
- 16712983; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280728(10)16712985
- Lot #
- 16712985; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280731(10)16720393
- Lot #
- 16720393; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280813(10)16739603
- Lot #
- 16739603; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280520(10)16607958
- Lot #
- 16607958; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280605(10)16632678
- Lot #
- 16632678; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280702(10)16677073
- Lot #
- 16677073; Reference
- Part / Item #
- (RPN)KCFW-12.0-35-45-RB-HFANL1-HC: Order Number G47701
- UDI
- (01)00827002477018(17)280711(10)16690408
- Lot #
- 16690408; Reference
- Part / Item #
- (RPN)KCFW-9.0-35-38.5-RB-RTPS-100: Order Number G13160
- UDI
- (01)00827002131606(17)280721(10)NS16703184
- Lot #
- NS16703184; Reference
- Part / Item #
- (RPN)KCFW-9.0-35-38.5-RB-RTPS-101: Order Number G13160
- UDI
- (01)00827002131606(17)280723(10)16707656
- Lot #
- 16707656; Reference
- Part / Item #
- (RPN)KCFW-9.0-35-38.5-RB-RTPS-102: Order Number G13160
- UDI
- (01)00827002131606(17)280609(10)16635746
- Lot #
- 16635746; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-RB-RTPS-100: Order Number G13081
- UDI
- (01)00827002130814(17)280612(10)16641423
- Lot #
- 16641423; Reference
- Part / Item #
- (RPN)KCFW-10.0-35-RB-RTPS-100: Order Number G13081
- UDI
- (01)00827002130814(17)280618(10)16649110
- Lot #
- 16649110; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-55-RB-RAABE: Order Number G36393
- UDI
- (01)00827002363939(17)280520(10)16607912
- Lot #
- 16607912; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606
- UDI
- (01)00827002126060(17)280711(10)16690398
- Lot #
- 16690398; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606
- UDI
- (01)00827002126060(17)280721(10)16703171
- Lot #
- 16703171; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606
- UDI
- (01)00827002126060(17)280529(10)16621284
- Lot #
- 16621284; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606
- UDI
- (01)00827002126060(17)280620(10)16653803
- Lot #
- 16653803; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-70-RB-RAABE: Order Number G12606
- UDI
- (01)00827002126060(17)280523(10)16614610
- Lot #
- 16614610; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-80-RB: Order Number G09442
- UDI
- (01)00827002094420(17)280723(10)NS16707657
- Lot #
- NS16707657; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-80-RB: Order Number G09442
- UDI
- (01)00827002094420(17)280515(10)NS16602824
- Lot #
- NS16602824; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-80-RB: Order Number G09442
- UDI
- (01)00827002094420(17)280609(10)NS16635753
- Lot #
- NS16635753; Reference
- Part / Item #
- (RPN)KCFW-9.0-38-80-RB: Order Number G09442
- UDI
- (01)00827002094420(17)280611(10)NS16638955
- Lot #
- NS16638955; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-30-RB: Order Number G13032
- UDI
- (01)00827002130326(17)280729(10)16716200
- Lot #
- 16716200; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280520(10)16607936
- Lot #
- 16607936; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280611(10)16638956
- Lot #
- 16638956; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280610(10)16637278
- Lot #
- 16637278; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280610(10)16637282
- Lot #
- 16637282; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280616(10)16644768
- Lot #
- 16644768; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280617(10)16647072
- Lot #
- 16647072; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280617(10)16647073
- Lot #
- 16647073; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280624(10)16657904
- Lot #
- 16657904; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280624(10)16657905
- Lot #
- 16657905; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280630(10)16673098
- Lot #
- 16673098; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280630(10)16673112
- Lot #
- 16673112; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280630(10)16673113
- Lot #
- 16673113; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280710(10)16688777
- Lot #
- 16688777; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280710(10)16688778
- Lot #
- 16688778; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280711(10)16690378
- Lot #
- 16690378; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280715(10)16693991
- Lot #
- 16693991; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280722(10)16704894
- Lot #
- 16704894; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280722(10)16704906
- Lot #
- 16704906; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280724(10)16709786
- Lot #
- 16709786; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280724(10)16709787
- Lot #
- 16709787; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280729(10)16716212
- Lot #
- 16716212; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280729(10)16716213
- Lot #
- 16716213; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280801(10)16721859
- Lot #
- 16721859; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280801(10)16721860
- Lot #
- 16721860; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280801(10)16721868
- Lot #
- 16721868; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280801(10)16721875
- Lot #
- 16721875; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280801(10)16721876
- Lot #
- 16721876; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280515(10)16602829
- Lot #
- 16602829; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280520(10)16607937
- Lot #
- 16607937; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280523(10)16614632
- Lot #
- 16614632; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280530(10)16623383
- Lot #
- 16623383; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280605(10)16632466
- Lot #
- 16632466; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280610(10)16637284
- Lot #
- 16637284; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280611(10)16638969
- Lot #
- 16638969; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280630(10)16673114
- Lot #
- 16673114; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-40-RB: Order Number G32233
- UDI
- (01)00827002322332(17)280613(10)16643080
- Lot #
- 16643080; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-80-RB: Order Number G13033
- UDI
- (01)00827002130333(17)280529(10)16621305
- Lot #
- 16621305; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-80-RB: Order Number G13033
- UDI
- (01)00827002130333(17)280523(10)16614616
- Lot #
- 16614616; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-80-RB: Order Number G13033
- UDI
- (01)00827002130333(17)280610(10)NS16637285
- Lot #
- NS16637285; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-80-RB: Order Number G13033
- UDI
- (01)00827002130333(17)280617(10)NS16647074
- Lot #
- NS16647074; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-80-RB: Order Number G13033
- UDI
- (01)00827002130333(17)280729(10)NS16716215
- Lot #
- NS16716215; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-RB: Order Number G13031
- UDI
- (01)00827002130319(17)280613(10)16643081
- Lot #
- 16643081; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-RB: Order Number G13031
- UDI
- (01)00827002130319(17)280715(10)16693981
- Lot #
- 16693981; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-RB: Order Number G13031
- UDI
- (01)00827002130319(17)280523(10)16614624
- Lot #
- 16614624; Reference
- Part / Item #
- (RPN)KCFW-10.0-38-RB: Order Number G13031
- UDI
- (01)00827002130319(17)280611(10)16638970
- Lot #
- 16638970; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-40-RB: Order Number G32373
- UDI
- (01)00827002323735(17)280605(10)16632469
- Lot #
- 16632469; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-40-RB: Order Number G32373
- UDI
- (01)00827002323735(17)280708(10)16683354
- Lot #
- 16683354; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-40-RB: Order Number G32373
- UDI
- (01)00827002323735(17)280619(10)16652152
- Lot #
- 16652152; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280806(10)16727445
- Lot #
- 16727445; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280529(10)16621277
- Lot #
- 16621277; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280603(10)16627324
- Lot #
- 16627324; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280529(10)16621278
- Lot #
- 16621278; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280731(10)16720362
- Lot #
- 16720362; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280522(10)16613273
- Lot #
- 16613273; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280523(10)16614607
- Lot #
- 16614607; Reference
- Part / Item #
- (RPN)KCFW-12.0-38-80-RB: Order Number G49487
- UDI
- (01)00827002494879(17)280528(10)16618070
- Lot #
- 16618070
Show 323 more code fieldsShow fewer
What the firm is doing
Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
DistributionShow detailsHide
Worldwide distribution.
Class IIWhat this means
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0993-2026
- FDA 510(k) clearance · K142829The device's official FDA premarket clearance record
- FDA device classification · DYBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1340The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cook IncorporatedSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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