FDA Medical Device Recalls (openFDA)
Thomas Medical Products Inc: Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton.
- Recall number
- Z-1085-04
- Recalling firm
- Thomas Medical Products Inc
- Product
- Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton.
- Status
- Terminated
- Initiated
- 2004-06-11
- Posted
- 2004-07-20
- Terminated
- 2005-06-27
- Reason
- Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
- Root cause
- Other
- Action
- The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.
- Quantity
- 39,605 kits
- Distribution
- The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
- Lot, serial or model codes
- All lot numbers are affected.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3010665433
- Firm city
- Malvern
- Firm state
- PA
- 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