Windstone Medical Recalls Lasik Trays Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 260 Lasik Tray 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 260 kits of Lasik Trays, part number DDS1045-2. These products are packaged for use in general clinical procedures and include Medtronic Covidien Curity Eye Pads.
The recall is being conducted due to the potential for the sterile packaging of the eye pads to be compromised. The affected lots are 100960, 103358, 79099, 81317, 82664, 82900, 85028, 86965, 88297, 89067, 89311, 94809, 95531, 98618, and 99932.
The products were 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. Healthcare facilities should stop using the affected products and contact the recalling firm for instructions.
The recalled product
- Product
- Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 260
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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