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U.S. Department of Health and Human Services

Class 2 Device Recall VPS Rhythm ECG Accessory Pack

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  Class 2 Device Recall VPS Rhythm ECG Accessory Pack see related information
Date Initiated by Firm May 17, 2018
Create Date July 08, 2018
Recall Status1 Terminated 3 on December 02, 2020
Recall Number Z-2383-2018
Recall Event ID 80299
510(K)Number K160925  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO

Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
Code Information Lot Number: 13F17A0288
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Karen Boylan
610-378-0131
Manufacturer Reason
for Recall		 Product pouch label may not easily identify the lot number, expiration date and associated symbols..
FDA Determined
Cause 2		 Labeling False and Misleading
Action On May 17, 2018, Arrow International issued Urgent Medical Device Recall Notices and Response Forms to impacted customers via FedEx 2-day. Customers were advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. 2.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. Soon after, a customer service representative will contact customers with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3.If you have no affected stock, please complete the Recall Acknowledgment 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 your receipt of the letter. Customers with questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 2070 units in total
Distribution US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA
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, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
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