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Open, Classified

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

FDA Recall Z-1160-2023 · Posted 2023-02-22

Recalling FirmS & MOHR AMERICA, S.A. DE C.V.
Recall StatusOpen, Classified
Product CodeCAH
Date Initiated2023-01-05
Product Quantity1,320 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"

Firm 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

Root Cause

Process control

Distribution Pattern

U.S. Nationwide distribution in the state of MN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 2020-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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