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Recall Observatory FDA recall evidence

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

February 01, 2023

Class III

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

    reason.no_named_rule · v1.0.0

    Product is labeled with an incorrect expiration date.