Windstone Medical Recalls Cataract Packs Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 7,508 cataract packs because the sterile packaging of the included eye pads may be compromised.
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 is classified as FDA Class II, and the hazard involves a potential breach of sterile packaging for a medical device used in clinical procedures, which poses a risk of harm even without reported injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 7,508 units of Cataract Packs. The affected products include part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. These kits are packaged for use in general clinical procedures.
The recall was initiated due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad, which is included in the kits, to be compromised. The agency has classified this as a Class II recall.
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. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and stop using the affected kits.
The recalled product
- Product
- Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(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
- 7,508
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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