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

Company

S & Mohr America, S.A. De C.V. Circuito De La Industria Poniente Lote 10 C Estado De Mexico Mexico

Recall Initiated

January 5, 2023

Posted

February 22, 2023

Recall Number

Z-1160-2023

Quantity

1,320 masks

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.

Lot / Code Info

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

Root Cause

Process control

Action Taken

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