The Recall Desk
HighFDA (Devices)·Z-1271-2017·Announced 2017-03-08

Medtronic Cover Light Handle Disposable Gloves Recalled for Sterility Compromise

Medtronic Cover Light Handle Disposable Gloves in custom Aligned Medical Solutions kits are being 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. The hazard involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

The U.S. Food and Drug Administration is recalling Medtronic Cover Light Handle Disposable Gloves that are part of custom Aligned Medical Solutions (AMS) kits. The recall was initiated because the gloves may contain splits or holes that compromise sterility.

The affected product is the Basic Tray, part number PSS1559(A, manufactured by Windstone Medical Packaging, Inc. A total of 69 kits were distributed across 27 states, including 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. Specific lot numbers and expiration dates are listed in the agency's recall record.

Healthcare facilities and consumers should stop using the affected gloves and contact the manufacturer or the FDA for further instructions on how to return or dispose of the product.

The recalled product

Product
Basic Tray, part number PSS1559(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
69

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 (9)

  • Lot number and expiration date 101652
  • 10/27/2019 87941
  • 9/23/2018 88545
  • 11/7/2018 88823
  • 12/2/2018 95649
  • 1/4/2019 96354
  • 1/18/2019 96815
  • 6/17/2019 97613
  • 4/18/2020

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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