Z-0346-06

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

Name: Z-0346-06 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per...
Creator: B. Braun Medical, Inc.
Published: 2005-09-01
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2005-09-01 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton on 2005-09-01. The reason FDA records is "Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0346-06
Status: Terminated
Initiated: 2005-09-01
Posted: 2006-01-06
Terminated: 2006-01-05
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.
Product code: DYB Introducer, Catheter
Reason for recall: Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
FDA root cause: Other
Action: The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
Quantity in commerce: 8000 units
Distribution: The product was shipped to two consignees that repack the product into their own kits.
Product codes and lots: Lot numbers 60710907 and 60710908

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)