The Recall Desk
ModerateFDA (Devices)·Z-1789-2017·Announced 2017-04-19

Windstone ENT Pack Recall Due to Compromised Sterile Packaging

Windstone Medical Packaging is recalling 16 ENT kits because the sterile packaging of the included Medtronic eye pads may be compromised.

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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 16 units of the ENT Pack, part number AMS2727. The recall is due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kits to be compromised.

The affected kits were distributed nationwide, including in California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin, and Wyoming. The specific lot numbers involved are 72702 and 78567.

Healthcare providers and consumers should stop using these kits and contact Windstone Medical Packaging for instructions on return or replacement.

The recalled product

Product
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Affected units
16

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)

  • Lot numbers: 72702 and 78567

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 18 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 18 products in this recall →