The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1357-2017·Announced 2017-03-08

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES Recalled for Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled 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 the hazard involves compromised sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall was initiated because the gloves may contain splits or holes that compromise sterility.

The affected product is the Percutaneous Entry Kit, manufactured by Windstone Medical Packaging, Inc. The recall involves 350 kits 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.

Healthcare facilities and consumers should stop using the affected gloves and kits immediately. Users should contact their supplier or the recalling firm, Windstone Medical Packaging, Inc., for instructions on return or replacement. The specific lot numbers and expiration dates for the affected units are listed in the agency's recall record Z-1357-2017.

The recalled product

Product
Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Kits
Hazard
Affected units
350

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 (14)

  • Lot number and expiration date 80492
  • 5/3/2018 82502
  • 6/8/2018 85302
  • 7/12/2018 88153
  • 11/13/2018 89116
  • 12/10/2018 89318
  • 11/22/2018 95070
  • 1/29/2019 95088
  • 11/14/2018 95580
  • 1/4/2019 95581
  • 1/4/2019 95582
  • 1/11/2019 95583
  • 1/24/2019 97115
  • 6/12/2019

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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