The Recall Desk
ModerateFDA (Devices)·Z-1792-2017·Announced 2017-04-19

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.

What this means for you

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
Affected units
260

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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.

See all 18 products in this recall →