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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Arterial Catheterization Kit

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  Class 2 Device Recall Arrow Arterial Catheterization Kit see related information
Date Initiated by Firm July 10, 2017
Create Date February 13, 2018
Recall Status1 Terminated 3 on September 14, 2018
Recall Number Z-0486-2018
Recall Event ID 78681
510(K)Number K810675  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Code Information Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Karen Boylan
610-378-0131
Manufacturer Reason
for Recall		 Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
FDA Determined
Cause 2		 Material/Component Contamination
Action On July 10, 2017, Arrow International distributed Urgent Medical Device Recall notice and acknowledgment forms to customers. Customers are advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products listed in the notice, so that the affected products can be returned to Arrow. 2. 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. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 18662466990.
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 = FMI and Original Applicant = ARROW INTL., INC.
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