Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (hemolysis) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 190 units of BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm. 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 due to a manufacturing specification change that was not implemented in units manufactured prior to July 15, 2014. This change is intended to reduce the incidence of hemolysis, which is the breakdown of red blood cells, during blood sampling through the PICC catheter.
The affected units are identified by batch/lot numbers 4732401, 4737713, 4752342, 4766669, and 4792819, with use-by dates ranging from March 31, 2016, to August 31, 2016. The devices 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 should stop using these specific units and contact Navilyst Medical for further instructions.
The recalled product
- 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 cent
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 190
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 (4)
- Batch/Lots: 4732401
- 4737713
- 4752342
- 4766669 & 4792819. Use By Date Range 2016-03-31 to 2016-08-31
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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