The Recall Desk
HighFDA (Devices)·Z-1266-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Basic Kits with Defective Gloves

Windstone Medical Packaging is recalling 216 Basic 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 involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 216 units of the Basic Kit, part number CMP1109(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. The recall covers specific lot numbers with expiration dates ranging from May 14, 2018, to September 27, 2019.

Consumers and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Basic Kit, part number CMP1109(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
216

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 (12)

  • Lot number and expiration date 84274
  • 5/14/2018 85771
  • 7/29/2018 86323
  • 9/5/2018 87540
  • 9/30/2018 88763
  • 12/2/2018 89683
  • 11/16/2018 95028
  • 1/5/2019 96659
  • 5/12/2019 97882
  • 6/4/2019 98262
  • 6/15/2019 99290
  • 9/27/2019

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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