RecallDepth

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

Company
Quest Medical, Inc.
Recall Initiated
February 26, 2015
Posted
April 2, 2015
Terminated
February 26, 2016
Recall Number
Z-1368-2015
Quantity
106 units
Firm Location
Allen, TX

Reason for Recall

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

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.

Lot / Code Info

Lot 40905AQ and 40601C

Root Cause

Labeling Change Control

Action Taken

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.

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