The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1966-2016·Announced 2016-06-22

Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 defect that poses a risk of harm (hemolysis) during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 2,716 units of Vaxcel PICC with PASV Catheter Kits. The affected products are labeled as 3F, 4F, and 5F and are indicated for establishing peripheral access to the central venous system for fluid administration and blood specimen withdrawal in adults, children, and infants.

The recall is due to a manufacturing defect in catheters produced prior to July 15, 2014. These units lack a specific manufacturing specification change that is designed to reduce the incidence of hemolysis, or the breakdown of red blood cells, during blood sampling through the catheter.

The affected units were distributed nationwide 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. Specific lot numbers and use-by dates are listed in the agency's recall record. Healthcare providers and patients should stop using the affected devices and contact the manufacturer for instructions on replacement or return.

The recalled product

Product
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
2,716

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 (17)

  • Batch/Lots: 1) 4732402
  • 4745359
  • 4824107
  • 4827333
  • 4835750
  • 4860987 & 48698433
  • 2) 4772713
  • 4786763
  • 4790018
  • 4817452 & 3) 4725793
  • 4745367
  • 4748673
  • 4756297
  • 4765394
  • 4773295
  • 4784468
  • 4788536 & 4845665 with Use By 2016-04-30.

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 →

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Same manufacturer · Navilyst Medical, Inc., an AngioDyamics Company

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