Windstone Medical Recalls Major Laparotomy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 32 Major Laparotomy 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 (splits/holes) compromises sterility, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 32 kits of Major Laparotomy Pack - NS, part number AMS4347. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. These 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 specific lot numbers and expiration dates involved are 78636 (4/16/2017) and 98273 (6/10/2019).
Healthcare facilities and consumers should stop using these kits immediately and contact Windstone Medical Packaging for instructions on returning the product. Using non-sterile gloves during surgical procedures poses a risk of infection.
The recalled product
- Product
- Major Laparotomy Pack - NS, part number AMS4347
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 32
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 78636
- 4/16/2017 98273
- 6/10/2019
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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