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 | Terminated |
| Reason | Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter |
| Product | Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 |
| Quantity | 62 cases (10/cs)=620 units |
| Distribution | AZ, CA, LA. IN, NC, TN, TX, VA |
| Initiated | 2015-06-19 |
| Classified | 2015-08-05 |
| Terminated | 2016-03-21 |
| Recall number | Z-2346-2015 |
| 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-2346-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71510/
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