—#42698

Product

7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot numbers 60710907 and 60710908

Why it was recalled

Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).

Root cause (FDA determination)

Other

Action the firm took

The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.

Recalling firm

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

Distribution

Distribution pattern: The product was shipped to two consignees that repack the product into their own kits.

Timeline

Recall initiated: 2005-09-01
Posted by FDA: 2006-01-06
Terminated: 2006-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.