Product Safety Recalls

Product Recall Tracker

Arrow International Inc Recall 88120

Description: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Arrow International Inc Recall 88120 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2068-2021
Event ID88120
Event DescriptionArrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Quantity48 units
Recall ReasonMarketed without a 510K
Device Classification20210721
Device Code InfoLot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
Center Classification Date20210713
Recall Initiation Date20210519
Recalling FirmArrow International Inc
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.