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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 pinssee related information
Date Initiated by FirmJuly 30, 2018
Create DateSeptember 19, 2018
Recall Status1 Terminated 3 on July 11, 2019
Recall NumberZ-3197-2018
Recall Event ID 80872
510(K)NumberK945229 
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
ProductARROW 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
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactSAME
610-378-0131
Manufacturer Reason
for Recall		Products are labeled with an incorrect expiration date
FDA Determined
Cause 2		Error in labeling
ActionArrow 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 Commerce7 eaches
DistributionUS in the state of PA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRF
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