Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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 INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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 INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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 INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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: 7A3842; Primary-DI 4046964338434; Unit of Use- DI 4046964338410; Lot 0062004706, Exp 31MAR2032; Lot 0062005799, Exp 30JUN2032; Lot 0062006415, Exp 31MAR2032; Lot 0062006416, Exp 31MAR2032; Lot 0062023397, Exp 30JUN2032; Lot 0062024887, Exp 31JUL2032 |
| Postal code | 18018-3524 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 21000 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 INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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-infusion-single-pk-model-c/FDA-Z-1482-2026
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