Product Wiki · Recalls · U.S. FDA — Device Enforcement

PRK Tray, part number DDS1044 Product packaged in a convenient manner… — recall Z-1797-2017

U.S. FDA — Device Enforcement · United States · 2017-03-16 · Class II

As described by U.S. FDA — Device Enforcement: PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1797-2017
Date of alert
2017-03-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Windstone Medical Packaging, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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