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
USBrand 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
Recalling Firm: B Braun Medical Inc
Reason for Recall / Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Product Description & Identification
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
Affected 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
Additional Source Details
| Field | Value |
|---|---|
| City | Bethlehem |
| State | PA |
| Event id | 98380 |
| Address 1 | 824 12th Ave |
| Address 2 | N/A |
| 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. |
| Postal code | 18018-3524 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 51300 units |
| Reason for recall | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260202 |
| Initial firm notification | Letter |
| Center classification date | 20260302 |
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Overview
- Recalling FirmB Braun Medical Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
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🚨 SAFETY ALERT: 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 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 Check if your household is affected: https://therecallfile.com/recalls/brand-name-b-braun-product-name-21ga-winged-inf-set-model-catalog-numb/FDA-Z-1483-2026
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