Class 2 Device Recall LIS27T Lacrimal Intubation Set

• Date Initiated by Firm: February 26, 2015
• Date Posted: April 02, 2015
• Recall Status: Terminated on February 26, 2016
• Recall Number: Z-1368-2015
• Recall Event ID: 70633
• Product Classification: Probe, lachrymal - Product Code HNL
• Product: LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
• Code Information: Lot 40905AQ and 40601C
• Recalling Firm/ Manufacturer: Quest Medical, Inc.; 1 Allentown Pkwy; Allen TX 75002-4206
• For Additional Information Contact: 972-390-9800
• Manufacturer Reason for Recall: Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
• FDA Determined Cause: Labeling Change Control
• Action: The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.
• Quantity in Commerce: 106 units
• Distribution: Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.