The Recall Desk
HighFDA (Devices)·Z-1972-2016·Announced 2016-06-22

Navilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

Navilyst Medical is recalling 1,127 Vaxcel 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) during blood sampling, which fits the criteria for a High severity score where injury has not yet been reported.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 1,127 units of Vaxcel PICC with PASV Intermediate Safety MST Kits. The affected products are identified by specific lot numbers and use-by dates ranging from April 30, 2016, to October 31, 2016. The recall covers 3F, 4F, and 5F sizes distributed worldwide, including the United States and various international markets.

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. Hemolysis refers to the rupture of red blood cells, which can occur when blood is drawn through the catheter. This defect is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected lots and contact Navilyst Medical for instructions on returning the products. Patients who have had these catheters implanted should consult their healthcare provider if they have concerns regarding blood sampling procedures.

The recalled product

Product
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fl
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
1,127

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 (12)

  • Batch/Lots: 1) 4738829
  • 2) 4732404
  • 4749417
  • 4774464
  • 4793677
  • 4819468
  • 4829479
  • 3) 4725435
  • 4745700
  • 4755306
  • 4764067
  • 4801103 & 4827331 with Use By Date 2016-04-30 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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