Skip to content
Recall Observatory FDA recall evidence

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

Z-1160-2023

January 05, 2023

Class III

Product summary

Firm
S & MOHR AMERICA, S.A. DE C.V.
Event
Event 91562
Status
Ongoing
Classification
Class III
Quantity
1,320 masks
Official record key
device-enforcement:Z-1160-2023

Official wording

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

Code information: Product Code: BC21087 Lot Number: SM6002.2207.12 Product Code: BC21088 Lot Number: SM6003.2507.12 Product Code: BC21273 Lot Number: SM6001.2207.12 Product Code: BC21089 Lot Number: SM6004.2607.12

Distribution pattern: U.S. Nationwide distribution in the state of MN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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