Reported Jul 29, 2015 · Terminated
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons,…
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
- RTPS Guiding Sheath Product UsageThe Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide
- Lot codes and dates
- Product Number
KCFW-10.0-35-RB-RTPS-100Catalog Number G13081
- Product Number
- Amount recalled
- 661
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
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
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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