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U.S. Department of Health and Human Services

Class 2 Device Recall Radial Artery Catheterization Kit w/sharp safety features

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  Class 2 Device Recall Radial Artery Catheterization Kit w/sharp safety features see related information
Date Initiated by Firm August 08, 2016
Date Posted September 07, 2016
Recall Status1 Terminated 3 on August 22, 2017
Recall Number Z-2741-2016
Recall Event ID 74986
510(K)Number K810675  
Product Classification Wire, guide, catheter - Product Code DQX
Product Radial Artery Catheterization Kit with Sharps Safety Features
Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Code Information Device Listing # D025180
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Alice Harper
610-378-0131 Ext. 3548
Manufacturer Reason
for Recall		 Shipping carton labeling error.
FDA Determined
Cause 2		 Process control
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990.
Quantity in Commerce 690 kits
Distribution Nationwide Distribution to OH, IN, TN, NC, and KY.
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 = DQX and Original Applicant = ARROW INTL., INC.
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