Class II — Atrium Medical Corporation
| Recalling firm | ATRIUM MEDICAL CORPORATION |
|---|---|
| Registered facility | Atrium Medical Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. |
| Product | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. |
| Quantity | 2460 units (246 cases, 10 units/case) |
| Distribution | US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX |
| Initiated | 2023-09-29 |
| Classified | 2023-12-01 |
| Recall number | Z-0484-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atrium Medical Corporation (Z-0484-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93408/
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