The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1341-2017·Announced 2017-03-08

Windstone Medical Minor Packs Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling 665 Minor Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 harm (infection) even though specific injury reports are not detailed in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 665 units of Minor Packs (part numbers AMS3782(B, AMS3782(C, CMP1560, PSS3518(B, and PSS3541(A). These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES from custom Aligned Medical Solutions (AMS) kits.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. 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.

Healthcare facilities and consumers should stop using these specific Minor Packs and contact Windstone Medical Packaging for instructions on return or replacement. The recall is classified as Class II by the FDA.

The recalled product

Product
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
665

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 100188
  • 10/19/2019 100884
  • 9/17/2019 84683
  • 5/27/2018 85122
  • 6/3/2018 85476
  • 8/17/2018 85717
  • 7/21/2018 86693
  • 9/3/2018 8695212/2/2018 87882
  • 11/11/2018 88612
  • 12/28/2018 88934
  • 11/28/2017 89105
  • 10/2/2018 89214
  • 11/19/2018 89473
  • 1/2/2019 89751
  • 1/21/2019 95234
  • 1/7/2019 96087
  • 1/9/2019 97240
  • 4/5/2018 97339
  • 5/13/2019 97525
  • 6/19/2019 97802

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 →

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