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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW ENDURANCE" Extended Dwell Peripheral Catheter System

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  Class 2 Device Recall ARROW ENDURANCE" Extended Dwell Peripheral Catheter System see related information
Date Initiated by Firm December 15, 2017
Date Posted March 14, 2018
Recall Status1 Terminated 3 on July 18, 2019
Recall Number Z-1194-2018
Recall Event ID 79474
510(K)Number K151513  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Code Information Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Elizabeth Norwood
866-246-6990
Manufacturer Reason
for Recall		 Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
FDA Determined
Cause 2		 Process control
Action Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.
Quantity in Commerce 305
Distribution Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
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 = FOZ and Original Applicant = Arrow Internation, Inc. (subsidiary of Teleflex Inc.)
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