The Recall Desk
HighFDA (Devices)·Z-1344-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in 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 may be 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 due to the possibility that the gloves may contain splits or holes, which could compromise sterility.

The affected product is the Minor/General/Ortho Pack, part number PSS3258(B. A total of 140 kits are involved in this recall. The affected lots include 100087 (expiration 9/21/2019), 85714 (expiration 7/29/2018), 94551 (expiration 1/29/2019), 95225 (expiration 1/30/2019), and 96081 (expiration 6/4/2019).

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. Consumers and healthcare facilities should check their inventory for these specific lot numbers and part numbers and stop using the affected gloves if found.

The recalled product

Product
Minor/General/Ortho Pack, part number PSS3258(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
140

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 (6)

  • Lot number and expiration date 100087
  • 9/21/2019 85714
  • 7/29/2018 94551
  • 1/29/2019 95225
  • 1/30/2019 96081
  • 6/4/2019

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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