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U.S. Department of Health and Human Services

Class 2 Device Recall Navilyst

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  Class 2 Device Recall Navilyst see related information
Date Initiated by Firm October 17, 2017
Create Date September 30, 2021
Recall Status1 Terminated 3 on June 14, 2022
Recall Number Z-2617-2021
Recall Event ID 88596
Product Classification unknown device name - Product Code N/A
Product Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-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.

Catalog Number: 60M701995
Code Information Lot Number: 5210162  (UDI): H96560M7019951
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact Saleem Cheeks
518-795-1174
Manufacturer Reason
for Recall		 Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
FDA Determined
Cause 2		 Error in labeling
Action Angiodynamics issued Recall Notifications Packages via Federal Express to 1 International Medical Facility on 2017-10-17. Letter states reason for recall, health risk and action to take: IMMEDIATELY " Stop using the product subject to recall. " Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to AngioDynamics, Inc. " Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. " If affected product is located in your institution, please can AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) 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); following the directions on this page and the Reply Verification Tracking Form. o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com o Fax Reply Verification Tracking Form: Ann: PICC Kit Product Description Recall Coordinator Fax number 1 800-782-1357.
Quantity in Commerce 4 boxes (5/each)= 20 eaches
Distribution Canada
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.
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