Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads 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 involves a medical device with a potential sterility compromise, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 4,065 units of Cataract Kits, part numbers CAT1467AM and CAT1538(B. 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 kits 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. Specific lot numbers are listed in the agency's recall record.
Healthcare providers should stop using the affected kits and contact Windstone Medical Packaging for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cataract Kit, part numbers CAT1467AM and CAT1538(B. 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
- 4,065
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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