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Recall Observatory FDA recall evidence

Device product

BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, 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-1987-2016

March 14, 2016

Class II

Product summary

Firm
Navilyst Medical, Inc., an AngioDyamics Company
Event
Event 73598
Status
Terminated
Classification
Class II
Quantity
190 units
Official record key
device-enforcement:Z-1987-2016

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: 4732401, 4737713, 4752342, 4766669 & 4792819. Use By Date Range 2016-03-31 to 2016-08-31

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

    reason.no_named_rule · v1.0.0

    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.