The Recall Desk
HighFDA (Devices)·Z-1304-2017·Announced 2017-03-08

Windstone Medical Recalls General Laparoscopy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 36 General Laparoscopy Packs because the disposable gloves included 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 involves a medical device where a defect (glove splits/holes) compromises sterility, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 36 units of the General Laparoscopy Pack, part number AMS4798. 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 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 involves two specific lots: Lot 84121 with an expiration date of 6/8/2018, and Lot 95178 with an expiration date of 9/28/2019.

Healthcare facilities and consumers should stop using these specific kits and contact Windstone Medical Packaging for further instructions or a replacement. The FDA has classified this as a Class II recall.

The recalled product

Product
General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
36

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 (3)

  • Lot number and expiration date 84121
  • 6/8/2018 95178
  • 9/28/2019

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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