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Copioumed

COPIOUMED INTERNATIONAL INC. · Model MS022W · UDI-DI 04719882250378

FXX

510(k) clearances

534

Adverse events

Recalls

318

Facilities

Description

Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only.

Recalls

Date	Firm	Reason
2024-11-08	O&M HALYARD, INC.	Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However,
2024-11-08	O&M HALYARD, INC.	Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However,
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-01-03	Owens & Minor Distribution, Inc.	Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops
2019-10-11	AMD Medicom Inc.	Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a
2019-10-11	AMD Medicom Inc.	Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a
2013-05-15	Maytex Corp	Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box
2003-06-03	Safco Dental Supply Co. Inc.	The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.