Reported Dec 31, 2025 · Ongoing
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2)…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
17 of 17 products
| # | Product as published |
|---|---|
| 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 codes and dates
111 of 111 products
Products covered by this recall # Barcodes Product as published 1 00827002491014Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC: Order Number G49101, UDI (01)00827002491014(17)280708(10)16683401, Lot Number 16683401 2 00827002491021Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280709(10)16685978, Lot Number 16685978 3 00827002491021Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280804(10)NS16724225, Lot Number NS16724225 4 00827002491021Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280808(10)NS16733075, Lot Number NS16733075 5 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280619(10)16652188, Lot Number 16652188 6 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280620(10)16653824, Lot Number 16653824 7 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662713, Lot Number 16662713 8 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280626(10)16662715, Lot Number 16662715 9 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280701(10)16675034, Lot Number 16675034 10 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280716(10)16696277, Lot Number 16696277 11 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280721(10)16703198, Lot Number 16703198 12 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280722(10)16704975, Lot Number 16704975 13 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280724(10)16709796, Lot Number 16709796 14 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280731(10)16720389, Lot Number 16720389 15 00827002562783Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278, UDI (01)00827002562783(17)280617(10)16647121, Lot Number 16647121 16 00827002477001Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280723(10)16707723, Lot Number 16707723 17 00827002477001Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280806(10)16727474, Lot Number 16727474 18 00827002477001Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280604(10)16629368, Lot Number 16629368 19 00827002477001Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC: Order Number G47700, UDI (01)00827002477001(17)280627(10)16664784, Lot Number 16664784 20 00827002562790Reference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC: Order Number G56279, UDI (01)00827002562790(17)280714(10)NS16692276, Lot Number NS16692276 - Amount recalled
- 7952 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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