FDA Medical Device Recalls (openFDA)
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 number
- Z-0346-06
- Recalling firm
- B. Braun Medical, Inc.
- Product
- 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
- Status
- Terminated
- Initiated
- 2005-09-01
- Posted
- 2006-01-06
- Terminated
- 2006-01-05
- Reason
- Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
- Root cause
- Other
- Action
- The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
- Quantity
- 8000 units
- Distribution
- The product was shipped to two consignees that repack the product into their own kits.
- Lot, serial or model codes
- Lot numbers 60710907 and 60710908
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28