Windstone Medical Packaging Recalls Extremity Tray Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 816 Extremity Tray 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 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 (sterility compromise in surgical gloves) poses a significant risk of serious injury or infection during surgery, fitting the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 816 units of the Extremity Tray, Kit number AMS1200(B and AMS1200(C. 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 FDA identified that the gloves may contain splits or holes, which compromises the sterility of the kit. This defect poses a risk of infection or other complications during surgical procedures. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Hospitals and healthcare facilities should stop using the affected kits immediately. The recall covers specific lot numbers and expiration dates ranging from March 2015 to September 2017. Facilities should check their inventory against the provided lot numbers and expiration dates to identify affected units.
The recalled product
- Product
- Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 816
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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