FDA Medical Device Recalls (openFDA)
Angiodynamics Inc. (Navilyst Medical Inc.): 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
- Recall number
- Z-2617-2021
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- 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
- Status
- Terminated
- Initiated
- 2017-10-17
- Posted
- not on file
- Terminated
- 2022-06-14
- Reason
- 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).
- Root cause
- 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
- 4 boxes (5/each)= 20 eaches
- Distribution
- Canada
- Lot, serial or model codes
- Lot Number: 5210162 (UDI): H96560M7019951
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28