Agency classClass IIOur severity:High FDA (Devices)·Z-1787-2017·Announced 2017-04-19

Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the 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 involves a medical device where the sterile packaging may be compromised, creating a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 172 kits of Dicken Eye Packs, part number CPA-3202-2. The recall is due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad to be compromised.

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. The recall covers specific lot numbers: 66434, 67357, 67740, 68573, 72552, 72934, 73659, 75891, 82964, 84240, 84810, 88958, 96250, and 99637.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected products. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their supplier for further guidance.

The recalled product

Product: Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical / Clinical Supplies
Hazard: sterility-compromise
infection-risk
Affected units: 172

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 →

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise