Windstone Medical Packaging Recalls Plastic General Packs with Defective Gloves
Windstone Medical Packaging is recalling 55 kits of Plastic General Packs because the included Medtronic gloves 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 risk-of-harm product (sterile medical gloves) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 55 kits of Plastic General Packs, part number AMS4215. The recall involves specific lots with expiration dates of September 26, 2018, December 21, 2019, and December 10, 2018.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects can compromise the sterility of the gloves, posing a risk to patient safety.
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. Consumers and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions.
The recalled product
- Product
- Plastic General Pack, part number AMS4215
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 55
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 (4)
- Lot number and expiration date 86311
- 9/26/2018 86750
- 12/21/2019 88475
- 12/10/2018
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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