FDA Medical Device Recalls (openFDA)
Thomas Medical Products Inc: SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.
- Recall number
- Z-0057-05
- Recalling firm
- Thomas Medical Products Inc
- Product
- SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.
- Status
- Terminated
- Initiated
- 2004-10-14
- Posted
- 2004-10-28
- Terminated
- 2006-01-24
- Reason
- Sheaths may fracture if exposed to excess fluorescent light
- Root cause
- Other
- Action
- The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.
- Quantity
- 805 kits
- Distribution
- The product was shipped to the label owner/distributor in CA.
- Lot, serial or model codes
- Lot number F5861 exp. 6/06 and Lot number 6724 exp. 8/06
- 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