Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology
Navilyst Medical is recalling specific BioFlo Hybrid PICC catheters because they lack a manufacturing 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 involves a medical device with a risk of harm (hemolysis) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc., an AngioDyamics Company, is recalling 275 units of BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm. The affected devices are identified by batch/lot numbers 4749414, 4766098, 4770315, 4776150, and 4790009, with use-by dates ranging from May 31, 2016, to September 30, 2016.
The recall was initiated because PICC catheters containing valves manufactured prior to July 15, 2014, lack a specific manufacturing specification change. This change is designed to reduce the incidence of hemolysis, which is the breakdown of red blood cells, during blood sampling through the catheter.
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, Netherlands, Spain, South Korea, Hong Kong, United Arab Emirates, and Italy. Healthcare providers and patients should stop using the affected devices and contact Navilyst Medical for further instructions.
The recalled product
- Product
- BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, 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
- 275
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: 4749414
- 4766098
- 4770315
- 4776150 & 4790009. Use By Date Range 2016-05-31 to 2016-09-30
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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FDA (Devices) · 2016-06-22
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