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U.S. Department of Health and Human Services

Class 2 Device Recall Walrus Arterial Embolectomy Catheter

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  Class 2 Device Recall Walrus Arterial Embolectomy Catheter see related information
Date Initiated by Firm July 07, 2016
Create Date September 30, 2016
Recall Status1 Terminated 3 on October 25, 2017
Recall Number Z-2911-2016
Recall Event ID 75014
510(K)Number K902327  
Product Classification Catheter, embolectomy - Product Code DXE
Product Walrus Arterial Embolectomy Catheter

The arterial embolectomy catheter is intended for use in removing arterial emboli.
Code Information Lot/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		 Arrow is recalling due to incorrect labeling of products.
FDA Determined
Cause 2		 Component design/selection
Action The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com, even if you have no affected stock. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 2,425 catheters
Distribution US Nationwide Distribution
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 = DXE and Original Applicant = CLINCAL INSTRUMENTS CORP.
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