Device product
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, 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
Z-1983-2016
Product summary
- Event
- Event 73598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 376 units
- Official record key
device-enforcement:Z-1983-2016
Official wording
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.
Code information: Batch/Lots: 4720503, 4778382, 4799263, 4824908, 4744027, 4752337, 4762746, 4786750, 4797579, 4824615, 4831212 & 4841018. Use By Date Range 2016-03-31 to 2016-12-31
Distribution pattern: Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Derived failure modes
-
Unknown
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.