Recall Weekly
Moderate riskFDA DeviceClass II

B. Braun 21GA winged infusion needle recalled for dull or broken needle tip

B. Braun Medical Inc is recalling certain 21-gauge winged infusion needles used to expand tissue expanders. The needle tips may be dull, blunt, or break during use, which could make the device difficult or impossible to use properly.

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

What to do

  1. Check your supply for the recalled lots: 0062004706, 0062005799, 0062006415, 0062006416, 0062023397, or 0062024887.
  2. Stop using any affected needles immediately.
  3. Contact your supplier or B. Braun Medical Inc for instructions on replacement or return.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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

This recall covers 3 products — see all of them.

Details

Units affected
21000 units
Illnesses reported
None reported
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Classification
Class II
Recall number
Z-1482-2026

In the FDA's words

Description
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 The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. 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 Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. Affected quantity: 21000 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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