The Recall Desk
HighFDA (Devices)·Z-1311-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

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 involves specific hand pack part numbers including AMS3640, AMS4213(A, AMS4311(A, AMS5343, and PSS1843(A. The total quantity affected is 102 6 kits.

The reason for the recall is that the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection or other health issues if the non-sterile gloves are used in medical procedures requiring sterile conditions.

The affected 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 stop using these gloves and contact the manufacturer or supplier for instructions on return or replacement.

The recalled product

Product
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard

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 100610
  • 8/6/2018 84646
  • 5/12/2017 84692
  • 7/28/2017 84730
  • 5/18/2017 84851
  • 6/1/2017 84859
  • 2/28/2017 85509
  • 7/1/2017 86309
  • 8/26/2018 86748
  • 8/17/2018 86839
  • 8/2/2018 86937
  • 10/14/2017 87631
  • 10/5/2017 87866
  • 9/15/2018 88208
  • 4/6/2017 88209
  • 7/31/2017 88266
  • 10/29/2018 88267
  • 1/5/2020 88279
  • 1/3/2019 88402
  • 11/2/2017 88875

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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