B. Braun 21GA winged infusion sets may have blunt needle tips
B. Braun Medical is recalling 21GA Winged Infusion Sets, model 7M2802, because the needle tip may be dull or blunt, difficult to advance, or may break.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a needle that may break or fail to advance during a procedure is a hazard, and no injuries are stated in the source.
Plain-English summary
B Braun Medical Inc is recalling the 21GA Winged Infusion Set, model 7M2802. The device is designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. About 51,300 units were distributed in Texas and Costa Rica. The FDA has classified this recall as Class II.
There is potential for the needle tip to be dull or blunt, difficult to advance, and/or break.
Affected product carries Primary-DI 4046964787102 and Unit of Use DI 4046964349904, across lots 0062003864, 0062004133, 0062006454, 0062028929, 0062037141 and 0062037691, with expiry dates from April 2032 to September 2032.
Facilities can identify affected devices by the model number, DIs and lot numbers above, and may contact B Braun Medical Inc for further information.
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
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion
- Affected units
- 51,300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Part of a larger recall action
This product is one of 3 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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