The Recall Desk
SevereFDA (Devices)·Z-0591-2021·Announced 2020-12-30

Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect could result in 'life-threatening adverse events' including 'embolization occluding blood flow to a vital organ' and 'hemorrhage,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe (4) classification.

Plain-English summary

Cook Inc. is recalling 611 units of Flexor Check-Flo Introducers, model RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229. The recall covers specific lot numbers distributed nationwide in the United States and globally to numerous countries. These medical devices are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

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

Healthcare providers and facilities that have received these devices should stop using them and contact Cook Inc. for further instructions on return or replacement. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.

The recalled product

Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 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 — Vascular Introducer
Hazard
Affected units
611

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 (16)

  • Lot Numbers: 13047587
  • 13089578
  • 13089579
  • 13126439
  • 13138927
  • 13197460
  • 13197462
  • 13203165
  • 13219551
  • 13221814
  • 13276233
  • 13312697
  • 13349024
  • 13380378
  • NS13094335
  • NS13226779

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 →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · device separation

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