The Recall Desk
HighFDA (Devices)·Z-1330-2017·Announced 2017-03-08

Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 1,056 Laparoscopic 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. The hazard involves compromised sterility in a medical device, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,056 units of Laparoscopic Packs, part numbers AMS2499, AMS2499(A, and AMS2499(B. 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, which could 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 July 25, 2018, to June 24, 2019.

Healthcare facilities and consumers should stop using these specific kits and contact Windstone Medical Packaging for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,056

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 84903
  • 7/25/2018 85836
  • 8/22/2018 86720
  • 9/30/2018 86873
  • 8/16/2018 87104
  • 8/30/2018 88049
  • 10/29/2018 88170
  • 10/5/2018 88378
  • 11/15/2018 88379
  • 12/2/2018 89576
  • 11/15/2018 89577
  • 12/2/2018 89721
  • 12/17/2018 94931
  • 1/29/2019 94932
  • 1/5/2019 95274
  • 1/27/2019 95596
  • 1/13/2019 95983
  • 6/10/2019 96593
  • 5/1/2019 97448
  • 5/28/2019 97653

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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