The Recall Desk
HighFDA (Devices)·Z-1292-2017·Announced 2017-03-08

Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 944 Dr. Landi EVLT Packs 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 944 units of the Dr. Landi EVLT Pack, part number AMS1483(E. The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in these custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise 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. The recall covers specific lot numbers and expiration dates ranging from December 2017 to February 2019.

Healthcare providers and consumers should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement.

The recalled product

Product
Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
944

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 (20)

  • Lot number and expiration date 100007
  • 2/26/2019 100008
  • 2/3/2019 100009
  • 2/10/2019 100322
  • 4/2/2019 101129
  • 2/21/2019 84854
  • 12/26/2017 85111
  • 12/1/2017 86047
  • 12/19/2017 86791
  • 5/7/2018 88616
  • 5/13/2018 88617
  • 6/11/2018 88845
  • 6/12/2018 89076
  • 10/22/2018 89175
  • 10/7/2018 89568
  • 11/9/2018 89715
  • 11/25/2018 94567
  • 10/23/2018 97120
  • 12/7/2018 97562
  • 11/27/2018 97771

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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