Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela PICC catheters because they lack a manufacturing change that reduces the risk of 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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 55 units of Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm. The affected units are identified by lot numbers 4718004, 4783051, 4788340, and 4796128, with use-by dates ranging from March 31, 2016, to August 31, 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, the Netherlands, Spain, South Korea, Hong Kong, the United Arab Emirates, and Italy. Healthcare providers and patients should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 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 — Catheters
- Hazard
- Affected units
- 55
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 (3)
- Batch/Lots: 4718004
- 4783051
- 4788340 & 4796128. 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
Same manufacturer · Navilyst Medical, Inc., an AngioDyamics Company
See all →- HighNavilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
- HighNavilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
- HighNavilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology
FDA (Devices) · 2016-06-22
- HighNavilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
- HighNavilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
Same hazard · hemolysis
See all →- CriticalFDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk
FDA (Devices) · 2023-08-23
- SevereDialysis Catheter Recall Due to Center Lumen Occlusion
FDA (Devices) · 2023-08-23
- SevereDialysis catheter recall: excessive lubricant causes center lumen obstruction
FDA (Devices) · 2023-08-23
- SevereDialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk
FDA (Devices) · 2023-08-23
- SevereFDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk
FDA (Devices) · 2023-08-23