Device product

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

Z-1798-2017

March 16, 2017

Class II

Product summary

Firm: Windstone Medical Packaging, Inc.
Event: Event 76774
Status: Terminated
Classification: Class II
Quantity: 500 kits
Official record key: device-enforcement:Z-1798-2017

Official wording

Reason: 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.

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

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

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

sterile packaging of the eye pad to be compromised