PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue
Summary
The FDA issued a Class III for PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials pa by Preat Corp. Reason: Product is labeled with an incorrect expiration date..
Details
Source
Device Recall
External ID
Z-1226-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Lot/Code Info: Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.
Quantity Affected: 652 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Santa Maria, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Preat Corp has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preat Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preat Corp have FDA actions?
Preat Corp has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1226-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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