ClearanceBrief
Recall Z-3089-2026 ยท FPA Set, Administration, Intravascular

B Braun Medical Inc

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

DateSep 2, 2026 (initiated Aug 4, 2026)
StatusOpen, Classified
ReasonSpecific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Root causeUnder Investigation by firm
ActionFirm 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.
Quantity25850
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K942988FILTERED EXTENSION SETS
B. Braun of America, Inc., Jul 14, 1995