Windstone Medical Vitrectomy Packs Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling 100 Vitrectomy 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 100 Vitrectomy Packs, part number AMS4952. These kits are packaged for use in general clinical procedures and include 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 lot numbers are 84384, 85615, 96957, and 99402.
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 kits and contact the manufacturer for instructions.
The recalled product
- Product
- Vitrectomy Pack, part number AMS4952 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
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers: 84384 85615 96957 99402
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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