Windstone Medical Packaging Recalls Custom Kits with Defective Gloves
Windstone Medical Packaging is recalling 840 custom kits 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 is classified as FDA Class II. The hazard involves compromised sterility in medical gloves, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 840 units of the Custom Pack - with Introducer Kit, part number TVS4011NI(L). The recall involves specific lots with expiration dates ranging from April 30, 2018, to May 25, 2019.
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 could compromise the sterility of the gloves.
The affected kits 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. Healthcare facilities and consumers should stop using these kits and contact Windstone Medical Packaging for instructions on return or replacement.
The recalled product
- Product
- Custom Pack - with Introducer Kit, part number TVS4011NI(L
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 840
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 (15)
- Lot number and expiration date 85014
- 4/30/2018 85448
- 7/14/2018 85937
- 8/23/2018 87713
- 8/9/2018 88092
- 11/18/2018 89342
- 10/17/2018 89974
- 12/5/2018 95212
- 12/3/2018 95725
- 12/19/2018 96882
- 12/9/2018 97051
- 5/27/2019 98088
- 5/2/2019 98423
- 5/25/2019 98852
- 5/14/2019
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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