Recall Z-1163-06 ยท DYB Introducer, Catheter
B. Braun Medical, Inc.
B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.
| Date | Jun 24, 2006 (initiated May 8, 2006) |
| Status | Terminated |
| Reason | Mislabeled-9F labeled units actually contain 10F devices |
| Root cause | Other |
| Action | The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits |
| Quantity | 9300 units |
| Distribution | The product was shipped to four consignees in FL, NY, CT, and Germany 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.