Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela 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 where a manufacturing defect increases the risk of hemolysis (a physiological harm) during blood sampling, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling Xcela Hybrid PICC with PASV Valve Technology, Catheter Kits (6F-55cm, UPN H965952410). The recall involves 2 units from batch/lot numbers 4743467 and 4759480, with use-by dates of April 30, 2016, and May 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 test results.
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 catheters and contact Navilyst Medical for further instructions.
The recalled product
- Product
- Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, 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 venous
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- 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: 4743467 & 4759480 Use By 2016-04-30 and 2016-05-31
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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