Recall Z-0056-05 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units
| Date | Oct 28, 2004 (initiated Oct 14, 2004) |
| Status | Terminated |
| 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 | 1170 kits |
| Distribution | The product was shipped to the label owner/distributor in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc., Jan 21, 1994 |