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FDAFDA · Food and drugs·Recall number Z-1783-2017

Cataract Kit, part numbers CAT1467AM and CAT1538(B. 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: 76819 76820 78070 78533 78534 78535 79189 79972 80673 80674 80696 81600 82230 83093 83094 83585 83899 84580 85193 86565 86956 87679 88237 88915 88917 89946 95370 95574 95575 96215 96720 97384 97669 99621 99816 99881 101220
Risk classification
Class II
Area (FDA)
device
Country
United States

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