Device product
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Z-1226-2023
Product summary
- Firm
- Preat Corp
- Event
- Event 91614
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 652 units
- Official record key
device-enforcement:Z-1226-2023
Official wording
Reason: Product is labeled with an incorrect expiration date.
Code information: Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. There was also government distribution. The country of Canada.
Derived failure modes
-
Unknown
Product is labeled with an incorrect expiration date.