Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES Recalled for Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because splits or holes may 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 device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise sterility.
The affected product is identified as Eye Tray, part number PSS1834 and PSS1834(A. A total of 310 kits are involved in this recall. The specific lot numbers and expiration dates are 100671 (9/28/2019), 101398 (10/13/2019), 84475 (5/26/2018), 86027 (9/2/2018), 87239 (9/5/2018), 89280 (11/16/2018), 95047 (1/24/2019), and 96991 (6/29/2019).
The 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 providers should check their inventory for these specific lot numbers and expiration dates and stop using the affected gloves if found.
The recalled product
- Product
- Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 310
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 (9)
- Lot number and expiration date 100671
- 9/28/2019 101398
- 10/13/2019 84475
- 5/26/2018 86027
- 9/2/2018 87239
- 9/5/2018 89280
- 11/16/2018 95047
- 1/24/2019 96991
- 6/29/2019
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.
See all 124 products in this recall →Related recalls
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