Reported Mar 2, 2016 · Terminated
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen…
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?
- Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
- Lot codes and dates
- RPN/Catalog number
C-PMS-250-RAC-PMS-251-RAC-PMS-300-RAC-PMS-300-RA-CHOPC-PMS-301J-RAC-PMS-301-RAC-PMS-400-RAC-PMSY-250-RA
- C-PMSY-300-RA C-PMSY-301-RA Lots
146 of 146 codes
604999861601956160212NS5898558NS6063328NS6178204NS617820658956056191185579319658003135800443580056958069815810905581091758244845824546582454758245485866984586698558669865870319588144758815195889496589190559114865922847592284859257425928632593944659394475939448597650260250166025094603376860349816034983605000060627386062742606767560676766075206607520760839366083954608398560839866129056614879061602366165591617497461752896191362
- RPN/Catalog number
- Amount recalled
- 12691
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
Using this product could cause serious injury, illness or death — stop using it now.
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