Windstone Medical Packaging Recalls Mohs Closer Packs Due to Sterility Risk
Windstone Medical Packaging is recalling 340 Mohs Closer Packs 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 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 medical device where a defect compromises sterility, creating a risk of harm (infection) without reported injuries or illnesses, which aligns with 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 340 units of Mohs Closer Packs, kit numbers PSS1827(A, PSS1827(B, and PSS1827(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 gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection to patients during surgical procedures. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
The affected lot numbers and expiration dates are: 58259 (12/20/2013), 55829 (12/25/2013), 59562 (5/1/2014), 59430 (5/3/2014), 63233 (10/23/2014), and 60818 (10/28/2014). Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 340
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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