Z-0199-2009

Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite...

Name: Z-0199-2009 Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite...
Creator: B. Braun Medical, Inc.
Published: 2008-09-17
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2008-09-17 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units... on 2008-09-17. The reason FDA records is "Product was assembled incorrectly and connected to the wrong part". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0199-2009
Status: Terminated
Initiated: 2008-09-17
Posted: 2008-10-24
Terminated: 2009-05-05
Recalling firm: B Braun Medical Inc
Product: Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Product was assembled incorrectly and connected to the wrong part.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.
Quantity in commerce: 3900 units
Distribution: Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
Product codes and lots: Item number 474515. Lot number 0061014615 exp 6/30/2013

Product code FPA

K955585Class IIV2 Injection SiteB.Braun Medical, Inc. / cleared 1996-05-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)