Recall Z-1297-2022— Atrium Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2022-04-21. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-21
- Firm location
- Merrimack, NH, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.