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U.S. Department of Health and Human Services

Class 2 Device Recall LIS27T Lacrimal Intubation Set

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  Class 2 Device Recall LIS27T Lacrimal Intubation Set see related information
Date Initiated by Firm February 26, 2015
Date Posted April 02, 2015
Recall Status1 Terminated 3 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/
Quest Medical, Inc.
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information Contact
Manufacturer Reason
for Recall
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
FDA Determined
Cause 2
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.