The Recall Desk
HighFDA (Devices)·Z-1295-2017·Announced 2017-03-08

Windstone Medical Recalls Extremity Packs Due to Potential Sterility Compromise

Windstone Medical Packaging is recalling 810 Extremity Packs because the disposable gloves inside 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 involves a medical device where sterility is compromised, which is a risk-of-harm product. The source text does not report any illnesses or injuries, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 810 units of Extremity Packs. The affected products include various part numbers such as AMS3240, AMS4764, AMS4788(A, PSS1798(A, PSS1842(A, and PSS2706. These 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.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise the sterility of the gloves, posing a risk to patient safety during medical procedures.

Healthcare facilities and consumers who have these specific Extremity Packs should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact their supplier or the manufacturer for further guidance on how to handle the affected units.

The recalled product

Product
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity P
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
810

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 100226
  • 9/11/2019 101400
  • 10/7/2019 84373
  • 5/28/2018 84678
  • 6/8/2018 84896
  • 5/26/2018 84959
  • 7/29/2018 85470
  • 2/23/2017 85505
  • 7/23/2018 85547
  • 8/23/2018 85695
  • 7/8/2018 85846
  • 8/5/2018 86258
  • 9/19/2018 86509
  • 9/28/2018 86663
  • 8/11/2019 86686
  • 9/9/2018 86908
  • 9/13/2018 87155
  • 9/16/2018 87730
  • 7/5/2017 87968
  • 9/6/2018 88008

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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