The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1284-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling Medtronic disposable gloves in custom kits because splits or holes may compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a risk of harm (sterility compromise) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 4,155 kits of Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves were part of custom Aligned Medical Solutions (AMS) kits with specific part numbers, including AMS4776, AMS5643, AMS6012, AMS6383, PSS2135(B, PSS2798(B, PSS2798(C, and PSS3463.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lots have expiration dates ranging from May 2018 to October 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.

Healthcare facilities and consumers should stop using these gloves immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B…
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
4,155

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 100084
  • 10/2/2019 100678
  • 10/22/2019 100683
  • 10/13/2019 100700
  • 9/5/2019 100771
  • 7/9/2019 100772
  • 7/23/2019 101188
  • 9/6/2019 101555
  • 9/9/2019 84253
  • 5/12/2018 84254
  • 5/25/2018 84377
  • 9/10/2018 84493
  • 5/28/2018 84494
  • 5/28/2018 84495
  • 6/22/2018 84681
  • 7/22/2018 84682
  • 7/29/2018 84853
  • 7/22/2018 84919
  • 6/3/2018 86006
  • 8/22/2018 86135

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 →

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