The Recall Desk
HighFDA (Devices)·Z-1358-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are being 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

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 could compromise their sterility.

The affected product is identified as Peri GYN, part number PSS2193(A. The recall involves 120 kits distributed across 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 86291 (9/19/2017), 87829 (10/7/2017), 96967 (4/21/2018), 98214 (6/19/2018), and 99585 (9/28/2018). Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected gloves if found.

The recalled product

Product
Peri GYN, part number PSS2193(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
120

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 86291
  • 9/19/2017 87829
  • 10/7/2017 96967
  • 4/21/2018 98214
  • 6/19/2018 99585
  • 9/28/2018

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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