FDA Medical Device Recalls (openFDA)
Preat Corp: PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
- Recall number
- Z-1226-2023
- Recalling firm
- Preat Corp
- Product
- PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2023-03-06
- Terminated
- not on file
- Reason
- Product is labeled with an incorrect expiration date.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 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. There was also government distribution. The country of Canada.
- Lot, serial or model codes
- Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EMA
- Firm FEI
- 2918719
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28