Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included 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 the defect (compromised sterility) poses a significant risk of infection or injury in a surgical setting, meeting the criteria for a Severe rating.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 145 Ortho Kits (Kit numbers PSS1039(A and PSS1039(B)) 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) included in the custom AMS kit. These gloves may contain splits or holes that compromise sterility.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers with expiration dates ranging from October 2014 to March 2017.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on returning or disposing of the product. Consumers are not directly affected as these are professional medical devices used in hospital settings.
The recalled product
- Product
- Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 145
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.
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