Z-1798-2017 Class II Terminated

Recalled by Windstone Medical Packaging, Inc. — Billings, MT

Recall Details

Product Type
Devices
Report Date
April 19, 2017
Initiation Date
March 16, 2017
Termination Date
June 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 kits

Product Description

Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

Code Information

Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020