Device 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
Z-3197-2018
Product summary
- Event
- Event 80872
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 eaches
- Official record key
device-enforcement:Z-3197-2018
Official wording
Reason: Products are labeled with an incorrect expiration date
Code information: Lot/Batch Number:16F18A0010 Use By: 2023-12-31
Distribution pattern: US in the state of PA
Derived failure modes
-
Unknown
Products are labeled with an incorrect expiration date