FDA-Device2017-04-19Class II

Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A 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
1,170 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A 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-1788-2017

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