B. Braun Medical, Inc. 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
Lot numbers 60710907 and 60710908
Products Sold
Lot numbers 60710907 and 60710908
B. Braun Medical, Inc. is recalling 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units due to Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
Recommended Action
Per FDA guidance
The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026