Reported Dec 30, 2020 · Terminated
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor…
Cook Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Lot codes and dates
- Lot Numbers
1302977613050652130826001308260113082603131013071310131013131722131410481314104913150557131553181315532213179880131863711318637213192133132118501323775913274344
- Lot Numbers
- Amount recalled
- 902
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
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. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Using this product could cause serious injury, illness or death — stop using it now.
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