Allergan Universal Fill Kit for tissue expanders recalled due to leakage risk
B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.
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: FDA Class II recall of a medical device with potential for bloodstream infection and life-threatening situations due to device leakage. No injuries or illnesses have been reported, making this a theoretical risk-of-harm situation.
Plain-English summary
B. Braun Medical, Inc. is recalling the Allergan Universal Fill Kit (REF No. 7M2804), a device used to inflate tissue expanders during surgical procedures. The recall affects 27,432 units distributed in the United States, Canada, and Singapore.
The devices are being recalled due to a manufacturing defect that may cause leakage. Leakage can interrupt tissue expansion therapy, increase the risk of bloodstream infection, and expose patients and healthcare workers to hazardous medication. The recall also cites potential for life-threatening situations requiring additional medical intervention.
The recall applies to devices with lot numbers 0061745499, 0061745500, 0061745501, and 0061792770.
The recalled product
- Product
- ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Surgical Device
- Hazard
- device-leakage
- bloodstream-infection-risk
- hazardous-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 (4)
- UDI-DI: 4046964823749 Lot 0061745499
- 0061745500
- 0061745501
- 0061792770
Distribution
Distributed nationwide across the United States.
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