Atrium Medical 20 Fr Trocar catheter — Class II medical device recall Z-0580-2017
Terminated recall by Atrium Medical Corporation, reported 2016-11-23, distributed in PR. Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product
| Recall number | Z-0580-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Hudson, NH, United States |
| Recall initiated | 2016-10-26 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2018-10-09 |
| Distributed | PR |
| Countries outside the US | AT, AU, BE, CA, CH, CR, DE, DO, EC, ES, FI, FR, HK, HN, IE, JM, KW, MX, NL, NZ, PA, PE, PT, QA, RO, SA, SE, VE, ZA |
| Reason classes | labeling |
| Model numbers | 8420 |
Product
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Reason for recall
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
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-0580-2017. 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.