Windstone Medical Recalls Morris Lap Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling Morris Lap Packs because the disposable gloves included in the kits may contain 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, posing a risk of infection or harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 25 kits of Morris Lap Packs, part number PSS3199(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. These gloves may contain splits or holes, which could compromise the sterility of the product.
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 for the recalled items are 84487 (expiring August 24, 2018) and 94598 (expiring November 11, 2018).
Healthcare facilities and consumers should stop using these specific kits immediately. Users should check their inventory for the part number PSS3199(A and the listed lot numbers and expiration dates. If the product matches the description, it should be quarantined and returned to the supplier or the recalling firm for credit or replacement.
The recalled product
- Product
- Morris Lap Pack, part number PSS3199(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 25
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 84487
- 8/24/2018 94598
- 11/11/2018
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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