The Recall Desk
ModerateFDA (Devices)·Z-1980-2016·Announced 2016-06-22

Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a manufacturing specification issue affecting blood sampling accuracy (hemolysis), which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 357 units of Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm. The affected products are identified by UPN H965952440 and H965952450 and have use-by dates ranging from March 31, 2016, to October 31, 2016. The recall covers specific batch and lot numbers: 4719661, 4746382, 4752893, 4790027, 4815993, 4830605, 4735062, 4759816, 4775599, 4785918, 4812167, and 4819162.

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 devices 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 contact Navilyst Medical for instructions on how to proceed with the recall.

The recalled product

Product
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, 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
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
357

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 (11)

  • Batch/Lots: 4719661
  • 4746382
  • 4752893
  • 4790027
  • 4815993
  • 4830605
  • 4735062
  • 4759816
  • 4775599
  • 4785918
  • 4812167 & 4819162. Use By Date Range 2016-03-31 to 2016-10-31

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

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Same hazard · hemolysis

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