Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, IR145 Kit

Batch/Lots: 4732400, 4753201, 4776149, 4783743, 4797578, 4819459, 4830558 & 4836573. Use By Date Range 2016-05-31 to 2016-12-31.

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, 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