Reported Jul 29, 2015 · Terminated
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended…
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?
- Ring Transjugular
- Intrahepatic Access Set Product UsageThe Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set
- consists of the following componentsFlexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide
- Lot codes and dates
- Product Number
RTPS-100-10.0Catalog Number G29769
- 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.
Want the full recall guide?
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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