Windstone Medical Packaging Recalls Basic Face Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 2,266 Basic Face Kits because the Medtronic gloves included 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 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 involves a risk-of-harm product (sterile surgical kits) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 2,266 units of the Basic Face Kit, including kit part numbers PS517A(B, PS517A(C, and PS517A(D. 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, which 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 and expiration dates ranging from March 2015 to February 2018.
Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on how to return or dispose of the product.
The recalled product
- Product
- Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2,266
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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