PlainRecalls
FDA Devices Moderate Class II Terminated

Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure

Reported: April 19, 2017 Initiated: March 16, 2017 #Z-1788-2017

Product Description

Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(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.

Details

Units Affected
1,170 kits
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Location
Billings, MT

Frequently Asked Questions

What product was recalled?
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure. Recalled by Windstone Medical Packaging, Inc.. Units affected: 1,170 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1788-2017.