The Recall Desk
ModerateFDA (Devices)·Z-1983-2016·Announced 2016-06-22

Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

Navilyst Medical is recalling 376 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 376 units of BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, as well as Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV, and BioFlo Hybrid PICC with PASV. The affected devices are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.

The recall is being conducted because PICC catheters containing valves manufactured prior to July 15, 2014, lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the catheter. The affected lots are 4720503, 4778382, 4799263, 4824908, 4744027, 4752337, 4762746, 4786750, 4797579, 4824615, 4831212, and 4841018, with use-by dates ranging from March 31, 2016, to December 31, 2016.

The devices were distributed nationwide in the United States and internationally to Australia, Greece, Sweden, Saudi Arabia, India, Canada, the United Kingdom, Brazil, Belgium, the Netherlands, Spain, South Korea, Hong Kong, the United Arab Emirates, and Italy. Healthcare providers and patients should contact Navilyst Medical for further instructions regarding the recall and replacement of these devices.

The recalled product

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 t
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — PICC Catheters
Hazard
Affected units
376

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 23 recalled by Navilyst Medical, Inc., an AngioDyamics Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 23 products in this recall →

Related recalls

Same manufacturer · Navilyst Medical, Inc., an AngioDyamics Company

See all →

Same hazard · hemolysis

See all →