Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 1,164 custom surgical 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 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. The hazard involves a risk of harm (infection due to compromised sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 1,164 units of Plastic Kit, Kit number CMP1084(B). 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) included in the custom AMS kit.
The gloves may contain splits or holes, which could compromise the sterility of the kit. This defect poses a risk of infection to patients if the non-sterile gloves are used during surgery.
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 and expiration dates ranging from March 2014 to October 2016. Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,164
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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