SA3000 intravenous adapters recalled for manufacturing defect causing leakage
B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.
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: This is an FDA Class II recall of a device with potential to cause serious harm through a manufacturing defect. Although no illnesses or injuries have been reported, the device poses significant risk of bloodstream infection and life-threatening complications, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the SA3000 VENTED MICRO SPIKE ADAPTER (Reference No. 418121) for intravenous use. The recall is due to a manufacturing defect that may cause the adapter to leak.
Leakage from these adapters may result in a delay of therapy. It also increases the risk of bloodstream infection and may expose both patients and healthcare workers to hazardous medications. In some cases, the device may create a potential for life-threatening situations requiring additional medical intervention.
Approximately 17,100 units have been distributed worldwide, including throughout the United States, Canada, and Singapore. The affected lots are 0061746019 and 0061755023. The device has UDI-DI: 4046964183454.
Healthcare facilities and individuals using these adapters should stop using them immediately and contact B. Braun Medical, Inc. for replacement or further instructions.
The recalled product
- Product
- SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- leakage
- bloodstream-infection
- medication-exposure
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 (1)
- UDI-DI: 4046964183454 Lots 0061746019 0061755023
Distribution
Distributed nationwide across the United States.
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