The Recall Desk
HighFDA (Devices)·Z-1363-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Podiatry Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 2,018 Podiatry Packs because the disposable gloves included may have splits or holes that 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 compromised sterility in medical devices, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 2,018 units of Podiatry Packs, including part numbers AMS2778, AMS2778(A, AMS3785(B, AMS3785(C, AMS4011(A, and PSS3422(A. The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in these custom Aligned Medical Solutions (AMS) kits may contain splits or holes that compromise sterility.

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. The recall covers specific lot numbers and expiration dates ranging from May 2018 to October 2019.

Consumers and healthcare providers should stop using the affected Podiatry Packs and contact Windstone Medical Packaging, Inc. for instructions on returning the products or obtaining a replacement.

The recalled product

Product
Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Podiatry Kits
Hazard
Affected units
2,018

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 83685
  • 5/17/2018 84193
  • 5/20/2018 84520
  • 5/25/2018 84823
  • 6/30/2018 84892
  • 6/16/2018 85953
  • 7/29/2018 85991
  • 7/15/2018 85992
  • 7/23/2018 86060
  • 7/11/2018 86346
  • 7/30/2018 86419
  • 8/25/2018 87109
  • 8/15/2018 87789
  • 9/23/2018 87886
  • 10/29/2018 88300
  • 9/23/2018 88301
  • 9/30/2018 88313
  • 9/23/2018 88331
  • 10/11/2018 88332
  • 10/22/2018 88333

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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