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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet

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  Class 2 Device Recall Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet see related information
Date Initiated by Firm March 24, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-1494-2014
Recall Event ID 67831
510(K)Number K121941  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Code Information lot #23F14A0375
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall		 Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
FDA Determined
Cause 2		 Labeling mix-ups
Action A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "
Quantity in Commerce 789
Distribution Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca
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 = LJS and Original Applicant = ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
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