The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0599-2021·Announced 2020-12-30

Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that separation could result in 'life-threatening adverse events,' which aligns with the rubric criterion for Critical severity involving known fatalities or death/serious injury reports. The potential for embolization and hemorrhage indicates a high risk of serious harm.

Plain-English summary

Cook Inc. has initiated a recall of the Flexor Check-Flo Introducer (Order Number G56236). This medical device is designed to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The recall affects 8,362 units distributed nationwide in the United States and globally to countries including Australia, Singapore, Austria, Belgium, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and others.

The reason for the recall is an increased likelihood of the introducer sheath separating at the proximal bond site during use. If this separation occurs, it could result in life-threatening adverse events. Potential consequences include increased procedural time, the need for intervention to retrieve a separated segment, embolization that occludes blood flow to a vital organ, vessel injury, and hemorrhage.

Consumers and healthcare providers should immediately stop using the affected product. Those who have the device should contact Cook Inc. for further instructions on how to return or dispose of the unit safely.

The recalled product

Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Manufacturer
Cook Inc.
Category
Medical Device — Introducer Sheath
Hazard
Affected units
8,362

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)

  • Lot Numbers: 13135824
  • 13140931
  • 13141304
  • 13141305
  • 13145950
  • 13145951
  • 13150436
  • 13150442
  • 13150443
  • 13153380
  • 13153383
  • 13153384
  • 13153385
  • 13155286
  • 13155289
  • 13155291
  • 13158203
  • 13158204
  • 13158208
  • 13162736

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 21 recalled by Cook Inc. 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 21 products in this recall →

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