The Recall Desk
ModerateFDA (Devices)·Z-1981-2016·Announced 2016-06-22

Navilyst Medical Recalls BioFlo and Xcela PICC Catheters

Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a manufacturing specification issue.

Plain-English summary

Navilyst Medical, Inc., an AngioDyamics Company, is recalling 60 units of BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410. The recall also covers the Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV, and BioFlo Hybrid PICC with PASV. These devices are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.

The recall is due to a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. PICC catheters containing valves manufactured prior to July 15, 2014, lack this specific change. The affected units are identified by batch/lot numbers 4788244, 4814218, 4835795, and 4842658, with use-by dates ranging from July 31, 2016, to January 31, 2017.

The affected products were distributed worldwide, including the United States (nationwide) 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 contact Navilyst Medical for further instructions regarding the replacement or return of these devices.

The recalled product

Product
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central v
Manufacturer
Navilyst Medical, Inc., an AngioDyamics Company
Category
Medical Device — PICC Catheters
Hazard
Affected units
60

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 (3)

  • Batch/Lots: 4788244
  • 4814218
  • 4835795 & 4842658. Use By Date Range 2016-07-31 to 2017-01-31

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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