FDA-Device2023-03-01Class III

abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

S & MOHR AMERICA, S.A. DE C.V.
Hazard

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

Sold states
U.S. Nationwide distribution in the state of MN.
Affected count
1,320 masks
Manufactured in
Circuito De La Industria Poniente Lote 10 C, N/A, Estado De Mexico, N/A, Mexico
Products
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2023

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