The Recall Desk
HighFDA (Devices)·Z-1320-2017·Announced 2017-03-08

Windstone Medical Recalls Knee Arthroscopy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 700 knee arthroscopy 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. The hazard involves compromised sterility in a surgical kit, which poses a risk of infection, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 700 units of Knee Arthroscopy Packs (part numbers AMS2610, AMS3236, and AMS3860). 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 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 with expiration dates ranging from May 2018 to September 2019.

Healthcare facilities and consumers who have these specific knee arthroscopy packs should stop using them and contact Windstone Medical Packaging for further instructions or a return.

The recalled product

Product
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
700

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 100023
  • 9/22/2019 100595
  • 9/1/2019 84529
  • 5/13/2018 84584
  • 5/26/2018 84728
  • 5/25/2018 85250
  • 7/22/2018 85273
  • 7/10/2018 85645
  • 8/1/2018 85845
  • 8/19/2018 87286
  • 8/11/2019 87350
  • 9/21/2018 87967
  • 9/24/2018 88173
  • 11/11/2018 88390
  • 11/21/2018 88627
  • 12/24/2018 89082
  • 10/3/2018 89422
  • 12/16/2018 89511
  • 11/13/2018 94573
  • 11/19/2018 94941

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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