The Recall Desk
HighFDA (Devices)·Z-1970-2016·Announced 2016-06-22

Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce 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 the source text does not explicitly report specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 5,566 units of Vaxcel PICC with PASV MST-60 Kits. The affected products are indicated for establishing peripheral access to the central venous system for the administration of fluids, including hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products, as well as for blood specimen withdrawal. The recall covers specific 3F, 4F, and 5F sizes with Use By Dates ranging from March 31, 2016, to September 30, 2017.

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. Hemolysis refers to the rupture of red blood cells, which can affect the accuracy of blood tests or cause other complications.

The affected units were distributed worldwide, including nationwide 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 providers and patients should stop using the affected lots and contact Navilyst Medical for further instructions.

The recalled product

Product
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — PICC Catheters
Hazard
Affected units
5,566

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 (20)

  • Batch/Lots: 1) 4724945
  • 4731137
  • 4738296
  • 4895232
  • 4912062
  • 4933353
  • 2) 4731139
  • 4738302
  • 4748674
  • 4776152
  • 3) 4721239
  • 4784467
  • 4810672
  • 4812161
  • 4821239
  • 4821511
  • 4824106
  • 4830612
  • 4832722
  • 4836599

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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