Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Summary
The FDA issued a Class II for Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catal by B Braun Medical Inc. Reason: Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label..
Details
Source
Device Recall
External ID
Z-3089-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Lot/Code Info: Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779
Quantity Affected: 25850
Reason for Recall
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-04
Company
Bethlehem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
B Braun Medical Inc has 266 FDA actions in our database, including 254 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 266 FDA actions in our database, including 254 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3089-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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