Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise
Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads 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 is classified as FDA Class II, and the hazard involves a potential compromise of sterile packaging for a medical device, which poses a risk of harm without reported injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 1,330 Eye Packs, part numbers WAL1085(B and WAL1085(C. These kits contain Medtronic Covidien Curity Eye Pads and are packaged for use in general clinical procedures.
The recall is being conducted because the sterile packaging of the eye pads within the kits may be compromised. This potential breach in sterility could affect the safety of the medical device for patients.
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. Specific lot numbers involved in the recall include 62736, 63388, 63389, 64189, 64190, 64586, 65070, 65171, 65307, 65714, 65715, 66342, 66343, 67079, 67080, 68165, 68166, 68234, 68641, 69264, 69536, and 69545. Healthcare providers and consumers should check their inventory for these specific part numbers and lot numbers and stop using the affected kits.
The recalled product
- Product
- Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 1,330
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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