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

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.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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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