The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0993-2026·Announced 2025-12-31

Check-Flo introducers recalled over products manufactured out of specification

Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites out of specification manufacturing with no stated consequence or reported harm.

Plain-English summary

Flexor Check-Flo Introducers and Sets are being recalled by Cook Incorporated, covering reference part numbers including KCFW-9.0-18/38-45-RB-ANL0-HC, KCFW-9.0-18/38-45-RB-ANL1-HC, KCFW-10.0-35-45-RB-HFANL0-HC and KCFW-12.0-35-45-RB-HFANL0-HC.

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 record lists 7,952 units, with order numbers, UDIs and lot numbers listed in the enforcement record including order number G49101 under UDI (01)00827002491014. Distribution was worldwide. The FDA has classified the action as Class II.

The record describes a manufacturing specification deviation and states no consequence or reported injuries. Facilities should quarantine affected lots and follow Cook's instructions.

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)…
Manufacturer
Cook Incorporated
Category
Medical Device — Introducer sheath
Hazard
Affected units
7,952

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.

Part of a larger recall action

This product is one of 3 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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