Recall Z-1368-2015 ยท HNL Probe, Lachrymal
Quest Medical, Inc.
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
| Date | Apr 2, 2015 (initiated Feb 26, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.