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FDAFDA · Food and drugs·Recall number Z-1790-2017

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

Published April 19, 2017 · Recall initiated: March 16, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Windstone Medical Packaging, Inc.
Distributor
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Lot
Lot numbers: 62980 63106 63387 63825 63826 64186 64490 64584 65937 75122 75329 77010 77089 77480 77664 78265 78312 78499 79042 79211 79944 79945 80709 80994 82316 82537 82538 82931
Risk classification
Class II
Area (FDA)
device
Country
United States

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