The Recall Desk
HighFDA (Devices)·Z-1799-2017·Announced 2017-04-19

Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise

Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Vitrectomy Kits, part number CMP1016(A, due to a potential defect in the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kit. The recall involves 440 kits 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 recall is classified as Class II by the FDA. The specific hazard is that the sterile packaging of the eye pad may be compromised, which could affect the sterility of the product. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The affected lot numbers are 75908, 78658, 79157, 79577, 81959, 83285, 84916, 85168, 86500, 87319, 88343, 88984, 89749, 96802, and 99415.

The recalled product

Product
Vitrectomy Kit, part number CMP1016(A. 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
440

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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.

See all 18 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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