Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the… — Class II medical device recall Z-1297-2022
Ongoing recall by Atrium Medical Corporation, reported 2022-07-06, distributed in AZ, IL, KS, LA, MI, NY, OH, OK…. Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper
| Recall number | Z-1297-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2022-04-21 |
| Classified | 2022-06-28 |
| Reported by FDA | 2022-07-06 |
| Distributed | AZ, IL, KS, LA, MI, NY, OH, OK, TX, VA |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 20650862150289 |
| Lot numbers | ME231010 |
| Model numbers | 15028 |
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 for recall
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
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-1297-2022. 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.