The Recall Desk
HighFDA (Devices)·Z-1369-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Shoulder Packs with Defective Gloves

Windstone Medical Packaging is recalling 875 Shoulder Pack kits because the included Medtronic gloves may contain 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 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 875 units of Shoulder Pack kits, including part numbers AMS2936, AMS3638, AMS3711(B, AMS4212, AMS6460, and PSS1852(A. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits.

The gloves may contain splits or holes that compromise sterility. The affected kits 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 the affected kits and contact Windstone Medical Packaging for instructions on returning the product.

The recalled product

Product
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
875

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 100412
  • 8/14/2018 100837
  • 10/19/2019 101181
  • 10/9/2019 83278
  • 5/27/2018 83634
  • 5/20/2017 84945
  • 6/24/2017 85147
  • 7/28/2017 85150
  • 7/15/2018 85258
  • 6/10/2018 85541
  • 7/14/2018 85554
  • 7/2/2018 85555
  • 7/7/2018 86259
  • 7/2/2017 86308
  • 9/20/2018 86488
  • 10/29/2018 86512
  • 9/28/2018 86688
  • 11/16/2019 86747
  • 8/3/2018 87122
  • 10/7/2017 87798

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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