Recall Z-1160-2023 ยท CAH Filter, Bacterial, Breathing-Circuit
S & MOHR AMERICA, S.A. DE C.V.
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
| Date | Feb 22, 2023 (initiated Jan 5, 2023) |
| Status | Open, Classified |
| Reason | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027" |
| 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 | 1,320 masks |
| Distribution | U.S. Nationwide distribution in the state of MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192713 | Altera Filter and HME/Filter Meditera Tibbi Malzeme San VE Tic AS, Mar 16, 2020 |