ARROW¿ Bipolar Electrode Catheter with shrouded pins — Class II medical device recall Z-3197-2018
Terminated recall by Arrow International Inc, reported 2018-09-26. Products are labeled with an incorrect expiration date
| Recall number | Z-3197-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-07-30 |
| Classified | 2018-09-19 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2019-07-11 |
| Quantity | 7 eaches |
| Reason classes | labeling |
| Lot numbers | 16F18A0010 |
| Expiration dates | 2023-12-31 |
Product
ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
Reason for recall
Products are labeled with an incorrect 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-3197-2018. 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.