FDA recall Z-1160-2023

S & MOHR AMERICA, S.A. DE C.V. · Class III · device

Product

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

Reason for recall

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

Distribution

U.S. Nationwide distribution in the state of MN.

Key facts

Status
Ongoing
Initiation date
2023-01-05
Report date
2023-03-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Estado De Mexico, N/A, Mexico

Primary source

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