Z-3089-2026Class II

Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

Name: Z-3089-2026 Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Creator: B Braun Medical Inc
Published: 2026-08-04
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2026-08-04 / Open, Classified / root cause: labeling and UDI

FDA source

B Braun Medical Inc began a recall of Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025 on 2026-08-04. The reason FDA records is "Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3089-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-04
Posted: 2026-09-02
Recalling firm: B Braun Medical Inc
Product: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Product code: FPA Set, Administration, Intravascular
Reason for recall: Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Firm began notifying customers via letter on August 4, 2026. Customers were informed that the shipper label incorrectly identifies the expiration date as 31JAN2031. The correct expiration date is listed on the individual product blisters as 01NOV2028. Customers were instructed to cease use and quarantine affected product. Product is not to be destroyed. Impacted product is to be returned to the firm for credit or replacement.
Quantity in commerce: 25850
Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada.
Product codes and lots: Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3089-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3089-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02

Product code FPA

K942988Class IIFiltered Extension SetsB. Braun of America, Inc. / cleared 1995-07-14

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)