Recall Weekly
Moderate riskFDA DeviceClass II

B. Braun 21GA Winged Infusion Set recalled for dull or broken needle tips

B. Braun Medical Inc. recalled certain winged infusion sets used to expand tissue expanders because the needle tips may be dull, blunt, or break during use. This could make it difficult to insert the needle or cause it to break inside the body. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All B. Braun recalls

What to do

  1. Check if you have any B. Braun 21GA Winged Infusion Set Model 7M2802 with lot numbers 0062003864, 0062004133, 0062006454, 0062028929, 0062037141, or 0062037691
  2. Stop using affected units immediately
  3. Contact your healthcare provider or B. Braun if you have questions about replacement or refund
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
51300 units
Illnesses reported
None reported
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Classification
Class II
Recall number
Z-1483-2026

In the FDA's words

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. 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. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. Affected quantity: 51300 units
Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

3 products in this recall

B. Braun winged infusion sets recalled for needle tip defect

B. Braun is recalling three models of 21-gauge winged infusion sets because the needle tip may be dull or blunt, difficult to advance, or break. The recall covers about 177,850 units distributed nationwide in the United States and in Costa Rica. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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