The Recall Desk
HighFDA (Devices)·Z-1355-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Ortho Packs with Defective Gloves

Windstone Medical Packaging is recalling 84 Ortho Pack kits because the included Medtronic gloves 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, and the hazard involves compromised sterility in a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 84 Ortho Pack kits, part number PSS3466(A. 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 documentation.

Consumers and healthcare facilities should stop using the affected Ortho Packs and contact Windstone Medical Packaging for instructions on how to return or dispose of the product.

The recalled product

Product
Ortho Pack, part number PSS3466(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
84

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 (8)

  • Lot number and expiration date 88900
  • 10/10/2018 94563
  • 1/4/2019 95875
  • 1/6/2019 96652
  • 3/8/2019 97170
  • 5/5/2019 98072
  • 5/1/2019 98589
  • 10/12/2019

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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