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FDA Medical Device Recalls (openFDA)

Quest Medical, Inc.: LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.

Recall number
Z-1368-2015
Recalling firm
Quest Medical, Inc.
Product
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Status
Terminated
Initiated
2015-02-26
Posted
2015-04-02
Terminated
2016-02-26
Reason
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
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
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.
Lot, serial or model codes
Lot 40905AQ and 40601C
510(k) numbers
not on file
PMA numbers
not on file
Product code
HNL
Firm FEI
3001665800
Firm city
Allen
Firm state
TX
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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