Windstone Eye Cataract Kits Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling Eye Cataract Packs because the sterile packaging of the included eye pad 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 is classified as FDA Class II and involves a risk of harm (compromised sterile packaging) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Eye Cataract Packs, part numbers AMS1359 and AMS1359-1. The recall involves 1,520 kits that were distributed nationwide to locations in California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin, and Wyoming.
The recall was initiated due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kits to be compromised. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected kits and contact Windstone Medical Packaging, Inc. for further instructions or a replacement.
The recalled product
- Product
- Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 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
- 1,520
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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