Windstone Medical Packaging Recalls Ortho Packs with Defective Gloves
Windstone Medical Packaging is recalling 84 Ortho Pack kits because the included Medtronic gloves 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 is classified as FDA Class II, and the hazard involves compromised sterility in a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 84 Ortho Pack kits, part number PSS3466(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. The gloves may contain splits or holes that compromise sterility.
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. Specific lot numbers and expiration dates for the affected units are listed in the official recall documentation.
Consumers and healthcare facilities should stop using the affected Ortho Packs and contact Windstone Medical Packaging for instructions on how to return or dispose of the product.
The recalled product
- Product
- Ortho Pack, part number PSS3466(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 84
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 (8)
- Lot number and expiration date 88900
- 10/10/2018 94563
- 1/4/2019 95875
- 1/6/2019 96652
- 3/8/2019 97170
- 5/5/2019 98072
- 5/1/2019 98589
- 10/12/2019
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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