Reported Dec 22, 2021 · Terminated
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Flexor Check-Flo Introducer
- Ansel Modification Model NumberKCFW-6.0-18/38-45-RB-ANL0-HC
- Order Number/GPNG44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature
- Lot codes and dates
- Lot Number13895370
- UDI(01)00827002441545(17)240415(10)13895370
- Amount recalled
- 50 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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