7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouche
FDA device recall Z-0346-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
- Action taken
- The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 8000 units
- Distribution
- The product was shipped to two consignees that repack the product into their own kits.
- Date initiated
- 2005-09-01
- Date posted
- 2006-01-06
- Date terminated
- 2006-01-05
- Location
- Allentown, PA
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