Windstone Medical Recalls Plastic Packs with Defective Gloves
Windstone Medical Packaging is recalling 204 plastic packs used in general surgery 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that compromises sterility in a surgical setting, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 204 units of Plastic Packs, Kit number AMS1833(A). These are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit.
The gloves may contain splits or holes that compromise sterility. The affected lots have expiration dates ranging from March 10, 2014, to November 19, 2016. The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on how to return or dispose of the products.
The recalled product
- Product
- Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 204
Distribution
Part of a larger recall action
This product is one of 150 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 150 products in this recall →Related recalls
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