The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1354-2017·Announced 2017-03-08

Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

Windstone Medical Packaging is recalling 664 Ortho Minor Packs because the included disposable gloves may contain 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 a medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 664 Ortho Minor Packs (part number AMS3710(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, which compromises the sterility of the product.

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 are listed in the agency's recall record.

Consumers and healthcare facilities should stop using the affected Ortho Minor Packs and contact Windstone Medical Packaging, Inc. for instructions on return or replacement.

The recalled product

Product
Ortho Minor Pack, part number AMS3710(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Orthopedic Kits
Hazard
Affected units
664

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 (14)

  • Lot number and expiration date 100234
  • 9/8/2019 84944
  • 6/4/2018 85366
  • 7/23/2018 85662
  • 9/29/2018 86669
  • 9/15/2018 87127
  • 11/21/2018 89042
  • 12/12/2018 89735
  • 11/12/2018 95813
  • 1/28/2019 96010
  • 1/26/2019 97466
  • 5/28/2019 98514
  • 6/30/2019 99386
  • 6/10/2019

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 →

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