The Recall Desk
HighFDA (Devices)·Z-1265-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Basic Face Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 965 Basic Face Kits 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 medical gloves, which poses a risk of harm (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 965 units of the Basic Face Kit, part number PS517A(D. 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 sterility.

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. Specific lot numbers and expiration dates for the affected units are listed in the official recall record.

Consumers and healthcare facilities should stop using the affected Basic Face Kits and contact Windstone Medical Packaging, Inc. for instructions on how to return or dispose of the product.

The recalled product

Product
Basic Face Kit, part number PS517A(D
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Kits
Hazard
Affected units
965

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 (17)

  • Lot number and expiration date 81973
  • 5/29/2018 82332
  • 5/13/2018 84698
  • 2/10/2018 84985
  • 8/6/2018 85899
  • 8/26/2018 86370
  • 8/1/2018 86729
  • 12/26/2018 89108
  • 11/15/2018 89302
  • 12/25/2018 89652
  • 11/19/2018 94627
  • 1/11/2019 95899
  • 5/21/2019 96504
  • 5/5/2019 97666
  • 6/26/2019 97832
  • 6/13/2019 99264
  • 9/3/2019

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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