Recall Z-1160-2023— S & MOHR AMERICA, S.A. DE C.V.
Class III · Ongoing
Class III FDA medical device recall by S & MOHR AMERICA, S.A. DE C.V., initiated 2023-01-05. It names one FDA 510(k) clearance: K192713. 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: Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027".
- Recalling firm
- S & MOHR AMERICA, S.A. DE C.V.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-01-05
- Firm location
- Estado De Mexico, N/A, Mexico
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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"
Data sourced from openFDA. This site is unofficial and independent of the FDA.