Navilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology
Navilyst Medical is recalling 157 units of Xcela Hybrid PICC catheters because they lack a manufacturing specification change that reduces the incidence 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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 157 units of Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm. The affected products are identified by UPNs H965952420 and H965952460 and include batch/lot numbers 4762475, 4780075, 4797006, 4807953, 4730240, and 4757886. The use-by dates for these units range from March 31, 2016, to September 30, 2016.
The recall is being conducted 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. The Xcela Hybrid PICC with PASV is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, and nutrients, as well as for blood sampling and power injection of contrast media.
The affected units were distributed worldwide, including nationwide 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 facilities should stop using the affected units and contact Navilyst Medical for further instructions.
The recalled product
- Product
- Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, 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
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 157
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 (5)
- Batch/Lots: 4762475
- 4780075
- 4797006
- 4807953
- 4730240 & 4757886. Use By Date 2016-03-31 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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