abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breath
FDA device recall Z-1160-2023 · posted 2023-02-22 · Open, Classified
Recall details
- Recalling firm
- S & MOHR AMERICA, S.A. DE C.V.
- 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"
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CAH
- Quantity affected
- 1,320 masks
- Distribution
- U.S. Nationwide distribution in the state of MN.
- Date initiated
- 2023-01-05
- Date posted
- 2023-02-22
- Location
- Estado, De Mexico, Mexico
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