The Recall Desk
HighFDA (Devices)·Z-1796-2017·Announced 2017-04-19

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.

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 (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
Affected units
376

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 →