PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue

FDA device recall Z-1226-2023 · posted 2023-03-06 · Open, Classified

Recall details

Recalling firm

Preat Corp

Reason for recall

Product is labeled with an incorrect expiration date.

Action taken

The recalling firm issued letters dated 1/30/2023 on 2/1/2023 via certified mail. The reason for recall was explained and the customer/user was instructed to discard or return the product to the recalling firm. A Medical Device Recall Return Response form was enclosed for the customer to acknowledge they have read and understand the recall instructions. If the product was implanted, they are to provide specific implant dates, the quantities implanted, and available tracking information. They are to indicate they have identified and notified their customers who were shipped the product and if they want the recalling firm to conduct the subrecall, they were to attach a list of customers.

Root cause

Process control

Status

Open, Classified

Product code

EMA

Quantity affected

652 units

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. Th

Date initiated

2023-02-01

Date posted

2023-03-06

Location

Santa Maria, CA