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Parker Quality & Compliance

PQC Reg Watch

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Device recall

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

FDA recall source

Recall number
Z-3089-2026
Event id
99550
Status
Ongoing
FDA classification
Class II
Recalling firm
B Braun Medical Inc
Report date
Sep 9, 2026
Posted
Sep 2, 2026
Initiated
Aug 4, 2026
Center classification date
Sep 2, 2026
Product code
FPA
Device type
Set, Administration, Intravascular
Reason
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Root cause
Under Investigation by firm
Quantity
25850
Code info
Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779
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.
Voluntary or mandated
Voluntary: Firm initiated
Related 510(k)s
K942988
Location
Bethlehem, PA, United States