Windstone Medical Recalls PRK Trays Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 20 PRK kits because the sterile packaging of the included eye pads 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, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 20 kits of PRK Trays (part number DDS1044). The recall is due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kits to be compromised.
The affected lots are 78709, 84777, and 103152. These 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.
Consumers and healthcare providers should stop using the affected PRK Trays and contact Windstone Medical Packaging for further instructions.
The recalled product
- Product
- PRK Tray, part number DDS1044 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
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers: 78709 84777 103152
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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