Z-1163-06

B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as...

Name: Z-1163-06 B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as...
Creator: B. Braun Medical, Inc.
Published: 2006-05-08
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2006-05-08 / Terminated / root cause: labeling and UDI

FDA source

B. Braun Medical, Inc. began a recall of 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... on 2006-05-08. The reason FDA records is "Mislabeled-9F labeled units actually contain 10F devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1163-06
Status: Terminated
Initiated: 2006-05-08
Posted: 2006-06-24
Terminated: 2006-08-22
Recalling firm: B Braun Medical Inc
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.
Product code: DYB Introducer, Catheter
Reason for recall: Mislabeled-9F labeled units actually contain 10F devices
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits
Quantity in commerce: 9300 units
Distribution: The product was shipped to four consignees in FL, NY, CT, and Germany that repack the product into their own kits.
Product codes and lots: Lot number 60745623

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)