The Recall Desk
HighFDA (Devices)·Z-1305-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls General Packs with Defective Gloves

Windstone Medical Packaging is recalling 1,501 General Packs 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 the hazard involves compromised sterility in medical devices, which poses a risk of harm even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,501 General Packs (part numbers AMS2967(A, AMS3239(A, AMS3709(B, AMS5341, and AMS5694) 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.

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 includes specific lot numbers and expiration dates ranging from February 2018 to September 2019.

Healthcare facilities and consumers should stop using the affected General Packs and contact Windstone Medical Packaging for further instructions or a return.

The recalled product

Product
General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Packs
Hazard
Affected units
1,501

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 100415
  • 9/23/2019 100737
  • 9/30/2019 100981
  • 10/20/2019 101069
  • 9/6/2019 101739
  • 10/19/2019 101816
  • 10/14/2019 83797
  • 5/12/2018 84203
  • 5/26/2018 84668
  • 5/17/2018 84793
  • 2/3/2019 85141
  • 6/8/2018 85421
  • 7/28/2018 85504
  • 8/30/2018 86008
  • 7/8/2018 86260
  • 9/9/2018 86481
  • 9/5/2018 86586
  • 9/27/2018 86774
  • 8/8/2018 86837
  • 9/12/2018 87291

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.

See all →

Same hazard · sterility compromise

See all →