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FDA-Device2026-03-11Class II

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

B Braun Medical Inc
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-1483-2026

Original summary

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 The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Model/Catalog Number: 7M2802; Primary-DI 4046964787102, Unit of Use- DI 4046964349904; Lot 0062003864, Exp 30APR2032; Lot 0062004133, Exp 30JUN2032; Lot 0062006454, Exp 31JUL2032; Lot 0062028929, Exp 31AUG2032; Lot 0062037141, Exp 30SEP2032, Lot 0062037691, Exp 30SEP2032. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. Affected quantity: 51300 units

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