FDA Medical Device Recalls (openFDA)
Navilyst Medical, Inc., an AngioDyamics Company: BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY 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
- Recall number
- Z-1981-2016
- Recalling firm
- Navilyst Medical, Inc., an AngioDyamics Company
- Product
- BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY 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
- Status
- Terminated
- Initiated
- 2016-03-14
- Posted
- not on file
- Terminated
- 2018-06-11
- Reason
- 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.
- Root cause
- Device Design
- Action
- Navilyst 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
- 60 units
- Distribution
- Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
- Lot, serial or model codes
- Batch/Lots: 4788244, 4814218, 4835795 & 4842658. Use By Date Range 2016-07-31 to 2017-01-31
- 510(k) numbers
- ["K021704"]
- PMA numbers
- not on file
- Product code
- LJS
- 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