Z-1368-2015 Class II Terminated
FDA device recall Z-1368-2015 was initiated by Quest Medical, Inc. on February 26, 2015 and is designated Class II. Reason for recall: Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels The recall status is terminated (terminated February 26, 2016). Affected quantity: 106 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- February 26, 2015
- Termination Date
- February 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 units
Product Description
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Reason for Recall
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
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.
Code Information
Lot 40905AQ and 40601C