Recall Z-1088-04 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long.
| Date | Jul 20, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.