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.
FDA Recall Z-1163-06 · Posted 2006-06-24
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2006-05-08
Date Terminated2006-08-22
Product Quantity9300 units
Reason for Recall
Mislabeled-9F labeled units actually contain 10F devices
Firm Action
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
Distribution Pattern
The product was shipped to four consignees in FL, NY, CT, and Germany that repack the product into their own kits.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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