Z-1368-2015Class II

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

Name: Z-1368-2015 LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures
Creator: Quest Medical, Inc.
Published: 2015-02-26
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2015-02-26 / Terminated / root cause: labeling and UDI

FDA source

Quest Medical, Inc. began a recall of LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures on 2015-02-26. FDA classified it as Class II and gives the reason as "Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1368-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-04-02
Terminated: 2016-02-26
Recalling firm: Quest Medical, Inc
Product: LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Product code: HNL Probe, Lachrymal
Reason for recall: Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Lot 40905AQ and 40601C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code HNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)