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.
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 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.
- 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
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.
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