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"

Field note

Send feedback

We'll only use this to respond to your feedback.