Recall Z-0297-06 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.
| Date | Dec 17, 2005 (initiated Nov 7, 2005) |
| Status | Terminated |
| Reason | mislabeled as 9.5F actually contains 10.5F |
| Root cause | Other |
| Action | The recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05. |
| Quantity | 445 kits |
| Distribution | The products were shipped to one distributor in CA and the label holder in MA. The products were further distributed to hospitals in CA, CO, IL, KY, MO, MS, NC, NE, NY, OH, PA, SC, and TX. |
| 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 |