The Recall Desk
HighFDA (Devices)·Z-1971-2016·Announced 2016-06-22

Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk During Blood Sampling

Navilyst Medical is recalling 210 Vaxcel PICC catheters 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 is classified as FDA Class II. The hazard involves a risk of harm (hemolysis) in a medical device where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 210 units of Vaxcel PICC with PASV Introducer Kits. The affected products are 4F catheters with UPN M001455910 and are labeled for prescription use only. These devices 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 is due to a manufacturing specification issue. PICC catheters containing valves that were manufactured prior to July 15, 2014, lack a specific manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the catheter. The affected lots are 4732403, 4776151, 4792223, and 4810671, all with a use-by date of August 31, 2015.

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

The recalled product

Product
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration age
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
210

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 (4)

  • Batch/Lots: 1) 4732403
  • 4776151
  • 4792223
  • 4810671 with Use By 2015-08-31.

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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