Z-3197-2018 Class II Terminated
FDA device recall Z-3197-2018 was initiated by Arrow International Inc on Jul 30, 2018 and is designated Class II. Reason for recall: Products are labeled with an incorrect expiration date The recall status is terminated (terminated Jul 11, 2019). Affected quantity: 7 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Jul 30, 2018
- Termination Date
- Jul 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 eaches
Product Description
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
Distribution Pattern
US in the state of PA
Code Information
Lot/Batch Number:16F18A0010 Use By: 2023-12-31
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3197-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026