Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 430 Peri GYN surgical 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, and the hazard involves compromised sterility in surgical kits, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 430 units of Peri GYN, Kit number PSS2193(A), which are convenience custom kits used for general surgery in hospital operating rooms. The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit 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 March 5, 2014, to September 8, 2016.
Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging for further instructions or a refund.
The recalled product
- Product
- Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 430
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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