B. Braun Medical, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
Lot number 60745623
Products Sold
Lot number 60745623
B. Braun Medical, Inc. is recalling B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is pack due to Mislabeled-9F labeled units actually contain 10F devices. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled-9F labeled units actually contain 10F devices
Recommended Action
Per FDA guidance
The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits
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 noticeDistribution
As reported by FDA
CT, FL, IN, NY
Page updated: Jan 10, 2026