B Braun Medical Inc: Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Descr
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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: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 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: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.
- Product quantity
- 105550 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bethlehem
- State
- PA
- Country
- United States
- Event id
- 98380
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