Biosense Webster's Reprocessed SOUNDSTAR¿ eco recall
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Why was Biosense Webster's Reprocessed SOUNDSTAR¿ eco 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577
- Product
- Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
- Recalling firm
- STERILMED, INC.
- Quantity
- 22
- Distribution
- US Distribution including the states of WA and CA.
- Recall date
- October 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)