The Recall Desk
HighFDA (Devices)·Z-1378-2017·Announced 2017-03-08

Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 1,787 Upper Extremity Packs because the Medtronic 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. The hazard involves compromised sterility in medical devices, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,787 Upper Extremity Packs (part number AMS4670) 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 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 and expiration dates ranging from June 2017 to September 2018.

Healthcare facilities and consumers should stop using these kits and contact Windstone Medical Packaging for instructions on how to return or dispose of the affected products.

The recalled product

Product
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,787

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 100052
  • 9/16/2018 84369
  • 6/20/2017 84721
  • 6/26/2017 84951
  • 6/21/2017 85377
  • 7/26/2017 86594
  • 10/8/2017 86595
  • 10/11/2017 87312
  • 10/24/2017 87990
  • 10/6/2017 88277
  • 10/26/2017 88668
  • 11/1/2017 89203
  • 12/16/2017 89605
  • 12/17/2017 94907
  • 12/28/2017 94968
  • 12/5/2017 95303
  • 2/27/2018 95476
  • 2/20/2018 96326
  • 2/1/2018 96619
  • 2/10/2018 96788

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 →