Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Vitrectomy Kits, part number CMP1016(A, due to a potential defect in the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kit. The recall involves 440 kits distributed nationwide, including in California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin, and Wyoming.
The recall is classified as Class II by the FDA. The specific hazard is that the sterile packaging of the eye pad may be compromised, which could affect the sterility of the product. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The affected lot numbers are 75908, 78658, 79157, 79577, 81959, 83285, 84916, 85168, 86500, 87319, 88343, 88984, 89749, 96802, and 99415.
The recalled product
- Product
- Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 440
Distribution
Part of a larger recall action
This product is one of 18 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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