Z-1160-2023Class III

abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care...

Name: Z-1160-2023 abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care...
Creator: S & Mohr America, S.a. De C.v.
Published: 2023-01-05
License: https://open.fda.gov/license/

S & Mohr America, S.A. de C.V. / initiated 2023-01-05 / Open, Classified / root cause: manufacturing process

FDA source

S & MOHR AMERICA, S.A. DE C.V. began a recall of abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask -... on 2023-01-05. FDA classified it as Class III and gives the reason as "Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1160-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-01-05
Posted: 2023-02-22
Recalling firm: S & Mohr America, S.A. de C.V.
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
Product code: CAH Filter, Bacterial, Breathing-Circuit
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"
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On or about 01/10/2023, the firm emailed a Customer Notification to customers notifying them that specific lots of Breathing Circuits were incorrectly label with the manufacturing dated as the expiration date for the product. The correct expiration dates range from 07/22/2027 to 07/26/2027 (5 year shelf-life). Customers are informed that the affected products can be used without risk to the patient up and until July 2027. For questions, contact Quality Assurance Department at +905426624107 Monday through Friday between 8:00 a.m. to 5:00 p.m. EST
Quantity in commerce: 1,320 masks
Distribution: U.S. Nationwide distribution in the state of MN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1160-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1160-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-22

Product code CAH

K192713Class IIAltera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS / cleared 2020-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)