Windstone Medical Packaging Recalls Plastic Packs with Compromised Sterile Eye Pads
Windstone Medical Packaging is recalling 376 plastic kits 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 376 plastic kits, part numbers AMS1028, AMS1028(A, and WAL1189. These kits contain Medtronic Covidien Curity Eye Pads and are packaged for use in general clinical procedures.
The recall is due to the potential for the sterile packaging of the eye pads to be compromised. The affected lots are 76028, 76762, 77415, 77811, 80676, 81907, 82972, 83238, 84514, 86860, 88156, 89013, 89567, 94566, 95941, 97769, 98479, 99356, 101279, and 102974.
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. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 376
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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