Class 2 Device Recall Safco Supergrade Earloop Masks

• Date Initiated by Firm: June 03, 2003
• Date Posted: June 21, 2003
• Recall Status: Terminated on March 24, 2004
• Recall Number: Z-0944-03
• Recall Event ID: 26382
• 510(K)Number: K801036
• Product Classification: Mask, Surgical - Product Code FXX
• Product: Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
• Code Information: all lots of product code 372-8114 (blue) and 372-8125 (pink)
• Recalling Firm/ Manufacturer: Safco Dental Supply Co. Inc.; 2121 Shermer; Northbrook IL 60062
• For Additional Information Contact: Mr. Neil Ingram; 800-621-2178
• Manufacturer Reason for Recall: The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
• FDA Determined Cause: Other
• Action: Recalled by letter dated 5/30/03, informing the dentists that the earloop masks were mislabled with the wrong particle filtration efficiency. Correction labels were included with the letter for the dentists to field correct the boxes of masks in their office inventory.
• Quantity in Commerce: 60,000 boxes
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FXX