HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow… — Class II medical device recall Z-0331-2017
Terminated recall by Arrow International Inc, reported 2016-11-09, distributed nationwide. Labeling inconsistency
| Recall number | Z-0331-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2016-09-02 |
| Classified | 2016-11-02 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2020-02-20 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 16F15A0072, 16F15C0114, 16F15D0003, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030 |
Product
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Reason for recall
Labeling inconsistency
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-0331-2017. 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.