The Recall Desk
HighFDA (Devices)·Z-1975-2016·Announced 2016-06-22

Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

Navilyst Medical is recalling 568 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 involves a medical device with a risk of harm (hemolysis) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 568 units of Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm. The affected products are identified by UPNs H965251290 and H965457420 and include specific batch numbers with use-by dates ranging from March 31, 2016, to October 31, 2016.

The recall is issued 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 tests.

The affected units were distributed worldwide, including in the United States and internationally to Australia, Greece, Sweden, Saudi Arabia, India, Canada, the United Kingdom, Brazil, Belgium, the Netherlands, Spain, South Korea, Hong Kong, the United Arab Emirates, and Italy. Healthcare facilities and distributors should stop using the affected lots and contact Navilyst Medical for instructions on return or replacement.

The recalled product

Product
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, 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 ve
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
568

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 (10)

  • Batch/Lots: 4721803
  • 4732391
  • 4767156
  • 4768679
  • 4784455
  • 4789995
  • 4809602
  • 4728559
  • 4752329
  • 4768072 & 4783738. 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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