Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.
What this means for you
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 risk-of-harm product (compromised sterile packaging) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 990 units of the Cataract Kit - Dr. Slingsby (part number CMP1017(B)). The recall involves kits containing Medtronic Covidien Curity Eye Pads.
The recall was initiated due to the potential for the sterile packaging of the eye pads to be compromised. This defect could affect the sterility of the medical device.
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 official recall record.
The recalled product
- Product
- Cataract Kit - Dr. Slingsby, part number CMP1017(B. 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
- 990
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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