The Recall Desk
HighFDA (Devices)·Z-1345-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions 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 involves a medical device where sterility is compromised, posing 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 Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is being conducted because the gloves may contain splits or holes that compromise sterility.

The affected product is the Morris Hysto Pack, part number PSS3198(A. A total of 156 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.

The specific lot numbers and expiration dates for the affected units are 101121 (10/5/2019), 101680 (10/27/2019), 83882 (7/8/2018), 87088 (8/16/2018), 87496 (9/24/2018), 88351 (11/11/2018), 89549 (12/22/2018), 94996 (1/30/2019), 97899 (6/15/2019), and 98769 (6/25/2019). Consumers and healthcare facilities should check their inventory for these specific lot numbers and expiration dates and stop using the affected gloves if found.

The recalled product

Product
Morris Hysto Pack, part number PSS3198(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
156

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 (11)

  • Lot number and expiration date 101121
  • 10/5/2019 101680
  • 10/27/2019 83882
  • 7/8/2018 87088
  • 8/16/2018 87496
  • 9/24/2018 88351
  • 11/11/2018 89549
  • 12/22/2018 94996
  • 1/30/2019 97899
  • 6/15/2019 98769
  • 6/25/2019

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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