Windstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging
Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
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 medical device with a potential sterile packaging compromise, which poses a risk of harm (infection) but has no reported injuries or illnesses in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 164 custom kits, part numbers PSS1111 and PSS1111(A, that contain Medtronic Covidien Curity Eye Pads. The recall is due to the potential for the sterile packaging of the eye pads to be compromised.
The affected 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. The recall includes kits with lot numbers 64496, 70752, 79598, 79966, 82199, 84036, 85170, 86682, 87625, 88001, 89215, 96462, and 100885.
Healthcare providers and consumers should stop using these kits and contact Windstone Medical Packaging for instructions on return or replacement.
The recalled product
- Product
- Custom Tray, part numbers PSS1111 and PSS1111(A. 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
- 164
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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