Z-1226-2023 Class III Ongoing
FDA device recall Z-1226-2023 was initiated by Preat Corp on February 1, 2023 and is designated Class III. Reason for recall: Product is labeled with an incorrect expiration date. The recall status is ongoing. Affected quantity: 652 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 652 units
Product Description
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Reason for Recall
Product is labeled with an incorrect expiration date.
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.
Code Information
Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.