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Terminated

LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.

FDA Recall Z-1368-2015 · Posted 2015-04-02

Recalling FirmQuest Medical, Inc.
Recall StatusTerminated
Product CodeHNL
Date Initiated2015-02-26
Date Terminated2016-02-26
Product Quantity106 units

Reason for Recall

Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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