Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging 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 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 169 Ophthalmic Packs, part numbers WAL1107(A and WAL1190, which 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 specific lot numbers involved are 87223, 88773, 89837, 95552, 97215, 97765, 100154, 100984, and 102837.
Healthcare providers and consumers should stop using these products and contact Windstone Medical Packaging for further instructions or a return.
The recalled product
- Product
- Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 169
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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