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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW PICC

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  Class 2 Device Recall ARROW PICC see related information
Date Initiated by Firm October 17, 2017
Create Date February 22, 2018
Recall Status1 Terminated 3 on April 21, 2020
Recall Number Z-0690-2018
Recall Event ID 79200
510(K)Number K121941  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product ARROW¿ PICC
powered by ARROW¿ VPS¿
Stylet
Code Information CDC 34041 VPS Lot# 23F17A0037 23F17B0035
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
610-378-0131
Manufacturer Reason
for Recall		 The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.
Quantity in Commerce 601 eaches
Distribution AZ, CA, GA, MA, MO, NY, VA
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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