Navilyst Medical Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 10 BioFlo Hybrid PICC catheter kits 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, and the hazard involves a manufacturing specification change to reduce hemolysis, which is a moderate risk without reported serious injuries or fatalities.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 10 units of BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410. The affected devices are identified by Batch/Lot 4806370 and have a use-by date of October 31, 2016.
The recall was 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 samples.
The affected products were distributed worldwide, including in the United States and internationally to Australia, Greece, Sweden, Saudi Arabia, India, Canada, Great Britain, Brazil, Belgium, the Netherlands, Spain, South Korea, Hong Kong, the United Arab Emirates, and Italy. Healthcare providers and patients should stop using the affected catheters and contact Navilyst Medical for further instructions.
The recalled product
- Product
- BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, 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 ven
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 10
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: 4806370 Use By 2016-10-31
Distribution
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
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