Navilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 150 units of Xcela PICC catheters manufactured before July 15, 2014, 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) in a medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 150 units of Xcela PICC with PASV Valve Technology Catheter Kits, 6F-55cm, UPN H965457410. 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 issue. PICC catheters containing valves manufactured prior to July 15, 2014, lack a specification change that reduces the incidence of hemolysis during blood sampling through the catheter. The specific lot number is 4815673, with a use-by date of October 31, 2016.
The affected units 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 facilities should stop using the affected devices and contact Navilyst Medical for instructions on return or replacement.
The recalled product
- Product
- Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, 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 system
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 150
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: 4815673 Use By 2016-10-31
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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