FDAClass IIApril 19, 2017

PRK Tray recall

PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure

Why was PRK Tray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 78709 84777 103152

Product
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
20 kits
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls