Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, 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 and hemorrhage, which aligns with the rubric criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Cook Inc. is recalling 228 units of the Flexor Check-Flo Introducer (RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223). These medical devices are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
The recall is due to 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, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
The affected units were distributed nationwide in the US and globally to numerous countries. Specific lot numbers are 13297248, 13318063, 13320595, 13334764, 13388304, 13435140, 13291880X, NS13246556, NS13265340, and NS13288123. Healthcare providers should stop using these devices and contact Cook Inc. for instructions on return or replacement.
The recalled product
- Product
- Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Manufacturer
- Cook Inc.
- Affected units
- 228
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 (10)
- Lot Numbers: 13297248
- 13318063
- 13320595
- 13334764
- 13388304
- 13435140
- 13291880X
- NS13246556
- NS13265340
- NS13288123
Distribution
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.
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