B Braun Medical Inc: Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- B Braun Medical Inc
- 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 / hazard
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- Recall initiated
- 2026-02-02
- Code info
- 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.
- Product quantity
- 51300 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bethlehem
- State
- PA
- Country
- United States
- Event id
- 98380
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