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Terminated

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

FDA Recall Z-0944-03 · Posted 2003-06-21

Recalling FirmSafco Dental Supply Co. Inc.
Recall StatusTerminated
Product CodeFXX
Date Initiated2003-06-03
Date Terminated2004-03-24
Product Quantity60,000 boxes

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K801036SURGICAL MASKAmerican Threshold Industries, Inc. · 1980-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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