Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a medical device with potential for significant injury (hemolysis) maps to a severity score of 4 (Severe).
Plain-English summary
Navilyst Medical, Inc., an AngioDynamics Company, is recalling 100 units of Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm. The affected units are identified by UPNs H965952430 and H965952470 and have a use-by date of August 31, 2015. The specific lot numbers involved are 4759481, 4807952, 4746868, 4752404, and 4788361.
The recall was initiated because PICC catheters containing valves manufactured prior to July 15, 2014, lack a manufacturing specification change. This change is designed to reduce the incidence of hemolysis, which is the breakdown of red blood cells, during blood sampling through the catheter. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Greece, Sweden, Saudi Arabia, 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
- Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, 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 cen
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 100
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: 4759481
- 4807952
- 4746868
- 4752404 & 4788361. Use By 2015-08-31
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
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