—#46388

Product

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 product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot number 60745623

Why it was recalled

Mislabeled-9F labeled units actually contain 10F devices

Root cause (FDA determination)

Other

Action the firm took

The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: The product was shipped to four consignees in FL, NY, CT, and Germany that repack the product into their own kits.

Timeline

Recall initiated: 2006-05-08
Posted by FDA: 2006-06-24
Terminated: 2006-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.