FDA-Device2026-03-11Class IIPROCESSING DEFECT
B. Braun 21GA Winged Infusion Set recalled for dull or broken needle tips
OTHERNationwide distribution
Stop using B. Braun infusion sets (Model 7M2802)
B. Braun Medical Inc. recalled certain winged infusion sets used to expand tissue expanders because the needle tips may be dull, blunt, or break during use. This could make it difficult to insert the needle or cause it to break inside the body. No injuries have been reported.
- Check if you have any B. Braun 21GA Winged Infusion Set Model 7M2802 with lot numbers 0062003864, 0062004133, 0062006454, 0062028929, 0062037141, or 0062037691
- Stop using affected units immediately
- Contact your healthcare provider or B. Braun if you have questions about replacement or refund
Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Sold states
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Affected count
51300 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2026More B Braun Medical Inc recalls
- FDA-Device2026-04-22B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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