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U.S. Department of Health and Human Services

Class 2 Device Recall Xcela PICC with PASV Valve Technology, IR145 Kit

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  Class 2 Device Recall Xcela PICC with PASV Valve Technology, IR145 Kit see related information
Date Initiated by Firm March 14, 2016
Create Date June 14, 2016
Recall Status1 Terminated 3 on June 11, 2018
Recall Number Z-1974-2016
Recall Event ID 73598
510(K)Number K021704  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Code Information Batch/Lots: 4712504, 4732394 & 4800179  Use By 2016-09-30
Recalling Firm/
Manufacturer		 Navilyst Medical, Inc., an AngioDyamics Company
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact
518-792-4112
Manufacturer Reason
for Recall		 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
FDA Determined
Cause 2		 Device Design
Action Navilyst Medical distributed Urgent Voluntary Medical Device Recall notification letters on March 14, 2016, and Reply Tracking forms to their customers via courier service. Customers were asked to immediately remove any affected (recalled) product from their inventory (whether in labs, central supply, shipping and receiving or any other location). Segregate this product in a secure location for return to Navilyst Medical. Immediately forward a copy of the recall notice to all sites to which you have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 Monday to Friday, 8 am - 7 pm, EST to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) by fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.
Quantity in Commerce 105 units
Distribution Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
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 = CATHETER INNOVATIONS, INC.
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