Reported Oct 15, 2014 · Terminated
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number…
Sterilmed, 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: STERILMED, INC. · 11400 73rd Ave N · Maple Grove, MN · 55369-5561
Is this the product you have?
- Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters
- Catalog Nos
M-5723-115Model Number BIO10438577
- Lot codes and dates
- Lot Numbers
171794517215741721575
- and 1723123 Catalog Nos
M-5723-115Model Number BIO10438577
- Lot Numbers
- Amount recalled
- 22
Where it was sold
Why it was recalled
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
This product could cause temporary or reversible health problems — stop using it.
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