FDAFDA · Food and drugs·Recall number Z-0059-2015
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Published October 15, 2014 · Recall initiated: September 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- STERILMED, INC.
- Distributor
- US Distribution including the states of WA and CA.
- Lot
- Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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