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U.S. Department of Health and Human Services

Class 2 Device Recall Discofix Stopcock Set

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 Class 2 Device Recall Discofix Stopcock Setsee related information
Date Initiated by FirmAugust 04, 2026
Date PostedSeptember 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3089-2026
Recall Event ID 99550
510(K)NumberK942988 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBrand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Code Information Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779
FEI Number 2521402
Recalling Firm/
Manufacturer		 B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
For Additional Information ContactAllison longenhagen
001-484-2408373
Manufacturer 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 2		Under 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.
Quantity in Commerce25850
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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