The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1312-2017·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 recalled because splits or holes may compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 compromised sterility, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product.

The affected product is identified as Hand Tray, part numbers PSS2365(F and PSS2365(G. A total of 1,416 kits are involved in this recall. The products were distributed 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.

Healthcare facilities and consumers should stop using the affected gloves and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
1,416

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 (20)

  • Lot number and expiration date 84418
  • 1/30/2017 85478
  • 5/15/2017 85479
  • 5/21/2017 86212
  • 1/27/2017 86213
  • 1/27/2017 86630
  • 1/14/2017 87353
  • 1/24/2017 87946
  • 1/30/2017 88345
  • 2/22/2017 89564
  • 2/19/2017 94774
  • 1/17/2017 95066
  • 1/30/2017 95322
  • 1/25/2017 95854
  • 2/18/2017 96363
  • 2/10/2017 96634
  • 2/7/2018 97251
  • 2/7/2018 97325
  • 2/18/2018 98448
  • 2/10/2018 98449

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 →

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Same manufacturer · Windstone Medical Packaging, Inc.

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