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
Recall
- Recall Number
- Z-1483-2026
- Event Number
- 98380
- Firm
- B Braun Medical Inc
- FEI Number
- 2521402
- Product Code
- LCJ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 2, 2026
- Posted
- March 2, 2026
- Address
- 824 12th Ave, Bethlehem, PA, 18018-3524
Description
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.
On February 2, 2026 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken: 1. Review the notice in its entirety and ensure that all users in your organization are aware and informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the hospital/healthcare facility level. 2. Examine inventory for affected product, cease use and quarantine product subject to recall. Do not destroy any affected product. 5. Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
51300 units