The Recall Desk
HighFDA (Devices)·Z-1974-2016·Announced 2016-06-22

Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

Navilyst Medical is recalling 105 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 specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 105 units of Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430. 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 defect in PICC catheters containing valves manufactured prior to July 15, 2014. These specific units lack a manufacturing specification change that reduces the incidence of hemolysis (the destruction of red blood cells) during blood sampling through the catheter.

The affected lots are 4712504, 4732394, and 4800179, with a use-by date of September 30, 2016. The products 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 should stop using these specific units and contact Navilyst Medical for instructions on return or replacement.

The recalled product

Product
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, 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 f
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
105

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: 4712504
  • 4732394 & 4800179 Use By 2016-09-30

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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