Recall Z-0346-06 ยท DYB Introducer, Catheter
B. Braun Medical, Inc.
7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
| Date | Jan 6, 2006 (initiated Sep 1, 2005) |
| Status | Terminated |
| Reason | Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR). |
| Root cause | Other |
| Action | The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem. |
| Quantity | 8000 units |
| Distribution | The product was shipped to two consignees that repack the product into their own kits. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.