FDA-Device2017-04-19Class II

Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure

Windstone Medical Packaging, Inc.
Hazard

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Sold states
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Affected count
1,520 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1790-2017

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