Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842...
FDA Recall #Z-1482-2026 — Class II — February 2, 2026
Product Description
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
Reason for Recall
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Recalling Firm
B Braun Medical Inc — Bethlehem, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21000 units
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Code Information
Model/Catalog Number: 7A3842; Primary-DI 4046964338434; Unit of Use- DI 4046964338410; Lot 0062004706, Exp 31MAR2032; Lot 0062005799, Exp 30JUN2032; Lot 0062006415, Exp 31MAR2032; Lot 0062006416, Exp 31MAR2032; Lot 0062023397, Exp 30JUN2032; Lot 0062024887, Exp 31JUL2032
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated