Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 438 BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces 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 hemolysis during blood sampling, which is a risk-of-harm condition where injury has not been explicitly reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 438 units of BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm. The affected products are identified by UPN H965458430 and H965458840 and include specific batch numbers with use-by dates ranging from May 31, 2016, to December 31, 2016.
The recall was 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 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 patients should stop using the affected catheters and contact Navilyst Medical for instructions on replacement or return. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, 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 t
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — PICC Catheters
- Hazard
- Affected units
- 438
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 (7)
- Batch/Lots: 4732400
- 4753201
- 4776149
- 4783743
- 4797578
- 4819459
- 4830558 & 4836573. Use By Date Range 2016-05-31 to 2016-12-31.
Distribution
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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- HighNavilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
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- HighNavilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
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