The Recall Desk
HighFDA (Devices)·Z-1294-2017·Announced 2017-03-08

Windstone Medical ENT Packs Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling 390 ENT 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 390 units of ENT Packs, part numbers AMS3237(A and AMS4214. These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product.

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 May 2018 to June 2019.

Healthcare facilities and consumers should stop using these specific ENT Packs immediately. Users should check their inventory for the part numbers and lot numbers listed in the official recall notice. If the product is found, it should be returned to the supplier or the recalling firm, Windstone Medical Packaging, Inc., for credit or replacement.

The recalled product

Product
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
390

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 (19)

  • Lot number and expiration date 84530
  • 5/25/2018 84588
  • 5/12/2018 85139
  • 7/14/2018 85655
  • 8/1/2018 86310
  • 9/26/2018 86480
  • 9/3/2018 86749
  • 9/21/2018 87287
  • 8/11/2019 88184
  • 9/4/2018 88318
  • 11/19/2018 88647
  • 10/5/2018 89495
  • 9/30/2019 89589
  • 12/10/2018 95103
  • 1/2/2019 96194
  • 1/18/2019 96922
  • 5/11/2019 97787
  • 6/9/2019 98676
  • 6/27/2019

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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