FDA recall Z-1483-2026

B Braun Medical Inc · Class II · device

Product

Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 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.

Distribution

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Key facts

Status
Ongoing
Initiation date
2026-02-02
Report date
2026-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2026