The Recall Desk
ModerateFDA (Devices)·Z-1984-2016·Announced 2016-06-22

Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

Navilyst Medical is recalling BioFlo PICC catheters manufactured before July 15, 2014, because they lack 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is hemolysis during blood sampling, which is a procedural risk rather than a direct injury or death, and no illnesses or injuries are reported in the source text.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 2 units of BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440. The affected units are identified by Batch/Lot 4824806 and have a Use By date of October 31, 2016. These 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 initiated 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. Hemolysis refers to the rupture of red blood cells, which can affect the accuracy of blood test results.

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

The recalled product

Product
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , 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 ve
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — PICC Catheter
Hazard
Affected units
2

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 (1)

  • Batch/Lots: 4824806 Use By 2016-10-31

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

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Same hazard · hemolysis

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