Device product
EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Z-1779-2018
Product summary
- Event
- Event 79950
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3137 retail units (313700 syringes)
- Official record key
device-enforcement:Z-1779-2018
Official wording
Reason: The retail shelf cartons may be labeled with an incorrect lot number.
Code information: Lot 45014
Distribution pattern: US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
Derived failure modes
-
Unknown
The retail shelf cartons may be labeled with an incorrect lot number.