FDA Device recall Z-0484-2024
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036 by Atrium Medical, citing A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0484-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-29 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN, TX |
Product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Identifiers
| code_info | UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24. |
|---|
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-0484-2024%22
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