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
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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
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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 |
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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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