FDA recall Z-1226-2023

Preat Corp · Class III · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2023-02-01
Report date
2023-03-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2023