The Recall Desk
HighFDA (Devices)·Z-0993-2026·Announced 2025-12-31

[pending] Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC;

Pending LLM rewrite. Source: FDA_DEVICE Z-0993-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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) K
Manufacturer
Cook Incorporated
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Reference 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
  • Reference 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
  • UDI (01)00827002491021(17)280804(10)NS16724225
  • Lot Number NS16724225
  • UDI (01)00827002491021(17)280808(10)NS16733075
  • Lot Number NS16733075
  • Reference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC: Order Number G56278
  • UDI (01)00827002562783(17)280619(10)16652188
  • Lot Number 16652188
  • UDI (01)00827002562783(17)280620(10)16653824
  • Lot Number 16653824
  • UDI (01)00827002562783(17)280626(10)16662713
  • Lot Number 16662713
  • UDI (01)00827002562783(17)280626(10)16662715
  • Lot Number 16662715
  • UDI (01)00827002562783(17)280701(10)16675034

Distribution

Distribution scope not specified by the agency.

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