FDA Device recall Z-1297-2022
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum by Atrium Medical, citing 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 16SEP20….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1297-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-21 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | AZ, IL, KS, LA, MI, NY, OH, OK, TX, VA |
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
Identifiers
| code_info | UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1297-2022%22
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