The Recall Desk
HighFDA (Devices)·Z-1367-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 a defect (splits/holes) could compromise sterility, posing a risk of infection or harm. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

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

The affected product is the Set-Up Pack, part number PSS1305(C. A total of 1,275 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.

Consumers and healthcare facilities should stop using these gloves immediately and contact Windstone Medical Packaging, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Set-Up Pack, part number PSS1305(C
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
1,275

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 100280
  • 9/22/2019 101104
  • 9/14/2019 84089
  • 6/29/2018 85293
  • 7/29/2018 85807
  • 8/21/2018 86209
  • 9/23/2018 86427
  • 8/9/2018 86627
  • 8/11/2019 87734
  • 9/29/2018 87934
  • 9/7/2018 87935
  • 11/21/2018 87936
  • 12/25/2018 87937
  • 12/29/2018 89476
  • 1/28/2019 95646
  • 1/10/2019 96062
  • 1/16/2019 96463
  • 3/8/2019 96464
  • 6/22/2019 96465
  • 5/28/2019 96466

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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