Supergrade Earloop Masks…

Date posted by the FDA

June 21, 2003

Status

Terminated

Filed by

Safco Dental Supply Co. Inc.

Product

Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062

Reason

The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

Distribution pattern

Nationwide

Quantity

60,000 boxes

Codes and lots

all lots of product code 372-8114 (blue) and 372-8125 (pink)

Recall started

June 3, 2003

Device type

Mask, Surgical

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0944-03

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0944-03. The agency record governs; check it and the company before acting.