The Recall Desk
HighFDA (Devices)·Z-1968-2016·Announced 2016-06-22

Navilyst Medical Recalls Vaxcel PICC Catheters with PASV Valve

Navilyst Medical is recalling Vaxcel PICC catheters with PASV valves manufactured before July 15, 2014, due to a lack of specification changes 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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Navilyst Medical, Inc., an AngioDyamics Company, is recalling 2,260 units of Vaxcel PICC with PASV IR-145 Kits. The affected products are labeled as 4F, 5F, and 6F and 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. The device is also used for blood specimen withdrawal in adults, children, and infants requiring intravenous therapy.

The recall is initiated 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. The affected units 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 and patients should stop using the affected Vaxcel PICC with PASV IR-145 Kits and contact Navilyst Medical for further instructions. The specific lot numbers and use-by dates for the recalled units are listed in the official FDA recall record Z-1968-2016.

The recalled product

Product
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administ
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheter
Hazard
Affected units
2,260

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 (6)

  • Batch/Lots: 1) 4748893
  • 4766101
  • 4784466
  • 4735032
  • 4738833
  • 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.

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

See all →

Same hazard · hemolysis

See all →