FDA recall Z-1297-2022

Atrium Medical Corporation · Class II · device

Product

Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

Reason for recall

Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date

Distribution

AZ IL KS LA MI NY OH OK TX VA

Key facts

Status: Ongoing
Initiation date: 2022-04-21
Report date: 2022-07-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2022