The Recall Desk
HighFDA (Devices)·Z-1261-2017·Announced 2017-03-08

Windstone Medical Arthroscopy Packs Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 1,081 arthroscopy kits because the disposable gloves inside 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 a medical device, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,081 Arthroscopy Packs (part numbers AMS2938, AMS3639, AMS4765, PSS1799, and PSS1845(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 the sterility of the medical device.

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. The recall covers specific lot numbers with expiration dates ranging from 2017 to 2018.

Healthcare facilities and consumers should stop using the affected arthroscopy packs immediately. Users should contact Windstone Medical Packaging, Inc. for instructions on returning the product or obtaining a replacement.

The recalled product

Product
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,081

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 Numbers and Expiration Dates 83622
  • 5/19/2018 84374
  • 5/24/2018 84729
  • 5/17/2017 84897
  • 5/26/2018 84946
  • 6/24/2017 85171
  • 6/9/2018 85363
  • 7/20/2017 85548
  • 7/15/2018 85696
  • 8/22/2018 85698
  • 7/21/2017 86510
  • 9/29/2018 86687
  • 9/5/2018 86889
  • 7/11/2017 86909
  • 9/12/2018 87156
  • 8/1/2018 87157
  • 9/5/2018 87159
  • 10/23/2017 87289
  • 10/17/2017 87978
  • 10/31/2017 88401

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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