Atrium Firm PVC Thoracic Catheter 36FR Straight — Class II medical device recall Z-0484-2024
Ongoing recall by Atrium Medical Corporation, reported 2023-12-13, distributed in AL, AZ, CA, FL, IA, IL, IN, MD…. A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration dat
| Recall number | Z-0484-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-09-29 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN, TX |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00650862150360 |
| Lot numbers | ME234686 |
| Model numbers | 15036 |
| Expiration dates | 2023-02-24 |
Product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason for recall
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0484-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.