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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit

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  Class 2 Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit see related information
Date Initiated by Firm June 08, 2016
Create Date December 07, 2016
Recall Status1 Terminated 3 on June 15, 2018
Recall Number Z-0715-2017
Recall Event ID 74948
510(K)Number K142616  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019

The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
Code Information Lot #: 4945781
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact Gary Barrett
518-792-4112
Manufacturer Reason
for Recall		 There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for your returned product. Promptly complete, sign and return the Reply Verification Tracking Form by email to recall@angiodynamics.com or by Fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.
Quantity in Commerce 50 cartons (boxes of 5)
Distribution Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
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 = NAVILYST MEDICAL, INC.
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