PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
- Company
- Preat Corp
- Recall Initiated
- February 1, 2023
- Posted
- March 6, 2023
- Recall Number
- Z-1226-2023
- Quantity
- 652 units
- Firm Location
- Santa Maria, CA
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.
Lot / Code Info
Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.
Root Cause
Process control
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.