The Recall Desk
HighFDA (Devices)·Z-1317-2017·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 no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES that were included 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 identified as the HSG Pack, part number PSS3287, manufactured by Windstone Medical Packaging, Inc. A total of 300 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 for the affected units include 86441 (8/16/2018), 87951 (12/1/2018), 89639 (12/29/2018), 94599 (1/21/2019), 94870 (11/19/2018), and 99799 (10/7/2019). Users should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
HSG Pack, part number PSS3287
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
300

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 (7)

  • Lot number and expiration date 86441
  • 8/16/2018 87951
  • 12/1/2018 89639
  • 12/29/2018 94599
  • 1/21/2019 94870
  • 11/19/2018 99799
  • 10/7/2019

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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