Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology
Navilyst Medical is recalling 445 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 AngioDyamics Company, is recalling 445 units of BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211, as well as Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV, and BioFlo Hybrid PICC with PASV. The affected products 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 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 affected units are from batches 4773627, 4780053, and 4782468, with use-by dates ranging from May 31, 2016, to July 31, 2016.
The products 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 facilities and consumers should stop using the affected devices and contact Navilyst Medical for further instructions.
The recalled product
- Product
- BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 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…
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — PICC Catheters
- Hazard
- Affected units
- 445
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 (2)
- Batch/Lots: 4773627
- 4780053 & 4782468. Use By Date Range 2016-05-31 to 2016-07-31
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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