The Recall Desk
HighFDA (Devices)·Z-1377-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may compromise sterility.

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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES contained in custom Aligned Medical Solutions (AMS) kits. The recall was initiated because the gloves may contain splits or holes that could compromise sterility.

The affected product is the Universal Pack, part number AMS2036, manufactured by Windstone Medical Packaging, Inc. A total of 15 kits were distributed to locations in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington.

The specific lot numbers and expiration dates for the recalled items are 87597 (expiring 2/28/2017) and 88967 (expiring 4/30/2017). Consumers and healthcare facilities should stop using these gloves and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Universal Pack, part number AMS2036
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
15

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 (3)

  • Lot number and expiration date 87597
  • 2/28/2017 88967
  • 4/30/2017

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 124 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 124 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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