Recall Z-3089-2026

B Braun Medical Inc · initiated August 4, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779

Reason for recall

Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

FDA-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-3089-2026
Initiated
August 4, 2026
Posted by FDA
September 2, 2026
Product code
FPA – Set, Administration, Intravascular
Quantity
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.
Recalling firm
B Braun Medical Inc, Bethlehem, PA

Official FDA recall record