Windstone Medical Setup Packs Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
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 500 units of Setup Pack, part number AMS3112(A. These products are packaged for use in general clinical procedures and 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 lots are 84197, 85135, 86063, 87112, 88181, 89030, 94937, 95806, 96599, 97277, 97705, 99303, and 100020.
The 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. Healthcare providers should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 500
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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