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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit

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 Class 2 Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kitsee related information
Date Initiated by FirmMarch 14, 2016
Create DateJune 14, 2016
Recall Status1 Terminated 3 on June 11, 2018
Recall NumberZ-1985-2016
Recall Event ID 73598
510(K)NumberK021704 
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
ProductBioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 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: 4773627, 4780053 & 4782468. Use By Date Range 2016-05-31 to 2016-07-31
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
ActionNavilyst 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 Commerce445 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LJS
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