FDA Medical Device Recalls (openFDA)
STERILMED, INC.: Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
- Recall number
- Z-0059-2015
- Recalling firm
- STERILMED, INC.
- Product
- Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
- Status
- Terminated
- Initiated
- 2014-09-24
- Posted
- 2014-10-09
- Terminated
- 2015-08-11
- Reason
- 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
- Root cause
- Process control
- Action
- Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.
- Quantity
- 22
- Distribution
- US Distribution including the states of WA and CA.
- Lot, serial or model codes
- Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577
- 510(k) numbers
- ["K110076"]
- PMA numbers
- not on file
- Product code
- OWQ
- Firm FEI
- 3001237663
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28