The Recall Desk
HighFDA (Devices)·Z-1967-2016·Announced 2016-06-22

Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

Navilyst Medical is recalling 328 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 involves a high-risk medical device where a defect increases the risk of hemolysis (a physiological injury) during use, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Navilyst Medical, Inc., an AngioDynamics Company, is recalling 328 units of Vaxcel PICC with PASV Introducer Kits. The affected products are labeled as 4F (UPN M001454560) and 5F (UPN M001454610) 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 specification issue. PICC catheters containing valves manufactured prior to July 15, 2014, lack a specific manufacturing change that reduces the incidence of hemolysis (the destruction of red blood cells) during blood sampling through the catheter. The affected lots include 4714745 (Use By 2016-03-31) and 4745413, 4819467, 4827954, 4725425, and 4726948 (Use By Date Range 2016-03-31 to 2016-11-30).

The products 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 facilities should stop using these specific lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, 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,
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — Catheters
Hazard
Affected units
328

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) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413
  • 4819467
  • 4827954
  • 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.

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

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Same hazard · hemolysis

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