IV Administration Sets and Gravity Infusion Kits Risk Backflow
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kits (Part Number AMS14994A) due to a potential for backflow of medication from secondary IV containers into primary IV containers. The recall affects 520 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall initiated as a voluntary precautionary measure. No reported illnesses, injuries, or deaths are mentioned in the source text. The hazard is a potential backflow risk that has not resulted in confirmed adverse events.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Custom Convenience Kits Pre Op Kit, Part Number AMS14994A (UDI-DI: B098AMS14994A0) due to a potential safety issue with gravity IV administration sets and pump administration sets used with B Braun infusion pumps (Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump). The issue is that medication from secondary (piggyback) IV containers may flow backwards into primary IV containers or other connections, and the kits may have the ability to prime (occlusion).
The recalled product was distributed nationwide in the states of Georgia, Oregon, Tennessee, and Washington. A total of 520 units are affected. The recall involves lot numbers 224792, 228566, 230105, 230853, and 234209.
Affected customers should immediately discontinue use of the recalled kits and contact Windstone Medical Packaging, Inc. for further instructions regarding replacement or return of the product.
The recalled product
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- backflow
- medication-delivery-error
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 (2)
- UDI-DI: B098AMS14994A0
- Lot Numbers: 224792 228566 230105 230853 234209
Distribution
Distributed nationwide across the United States.
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