SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in
FDA device recall Z-0056-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Sheaths may fracture if exposed to excess fluorescent light
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1170 kits
- Distribution
- The product was shipped to the label owner/distributor in CA.
- Date initiated
- 2004-10-14
- Date posted
- 2004-10-28
- Date terminated
- 2006-01-24
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE (K934901) | Thomas Medical Products, Inc. | 1994-01-21 |