The Recall Desk
HighFDA (Devices)·Z-1793-2017·Announced 2017-04-19

Windstone Medical Minor Operation Kit Recall Due to Sterile Packaging Concerns

Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

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: The recall involves a potential breach of sterile packaging for a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 700 units of the Minor Operation Kit, part number AMS1530. These kits are packaged for use in general clinical procedures and contain Medtronic Covidien Curity Eye Pads.

The recall is being issued due to the potential for the sterile packaging of the eye pads to be compromised. This defect could affect the sterility of the product.

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 81885, 84227, 89474, 98076, and 99390. Users should check their inventory for these lot numbers and stop using the affected kits.

The recalled product

Product
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
700

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: 81885 84227 89474 98076 99390

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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