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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW Bipolar Electrode Catheter with shrouded pins

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  Class 2 Device Recall ARROW Bipolar Electrode Catheter with shrouded pins see related information
Date Initiated by Firm July 30, 2018
Create Date September 19, 2018
Recall Status1 Terminated 3 on July 11, 2019
Recall Number Z-3197-2018
Recall Event ID 80872
510(K)Number K945229  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
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
Code Information Lot/Batch Number:16F18A0010 Use By: 2023-12-31
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
610-378-0131
Manufacturer Reason
for Recall		 Products are labeled with an incorrect expiration date
FDA Determined
Cause 2		 Error in labeling
Action Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.
Quantity in Commerce 7 eaches
Distribution US in the state of PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = ARROW INTL., INC.
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