Product Wiki · Recalls · U.S. FDA — Device Enforcement

BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit… — recall Z-1981-2016

U.S. FDA — Device Enforcement · United States · 2016-03-14 · Class II

As described by U.S. FDA — Device Enforcement: 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 int

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1981-2016
Date of alert
2016-03-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Navilyst Medical, Inc., an AngioDyamics Company
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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