The Recall Desk
ModerateFDA (Devices)·Z-1921-2026·Announced 2026-04-29

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.
Category
Medical Device — IV Administration / Infusion
Hazard
Affected units
520

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Windstone Medical Packaging, 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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · backflow

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