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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW PICC powered by ARROW VPS Stylet

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  Class 2 Device Recall ARROW PICC powered by ARROW VPS Stylet see related information
Date Initiated by Firm June 01, 2017
Create Date November 28, 2017
Recall Status1 Terminated 3 on April 13, 2020
Recall Number Z-0181-2018
Recall Event ID 77589
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
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
Code Information Lot/Batch Number: 23F16K0055
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
866-246-6990
Manufacturer Reason
for Recall		 There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. 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 the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 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 the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.
Distribution Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
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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