B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nons
FDA device recall Z-1163-06 · posted 2006-06-24 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Mislabeled-9F labeled units actually contain 10F devices
- Action taken
- The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 9300 units
- Distribution
- The product was shipped to four consignees in FL, NY, CT, and Germany that repack the product into their own kits.
- Date initiated
- 2006-05-08
- Date posted
- 2006-06-24
- Date terminated
- 2006-08-22
- Location
- Allentown, PA
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