Device product
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Z-1368-2015
Product summary
- Event
- Event 70633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 106 units
- Official record key
device-enforcement:Z-1368-2015
Official wording
Reason: Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Code information: Lot 40905AQ and 40601C
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.
Derived failure modes
-
Unknown
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels