Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of 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 medical device with a risk of harm (hemolysis) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc., an AngioDyamics Company, is recalling 1,786 units of Vaxcel PICC with PASV MST-30 Kits. The affected products are labeled as 4F, 5F, and 6F sizes with specific Universal Product Numbers (UPNs) and are indicated for establishing peripheral access to the central venous system for fluid administration and blood specimen withdrawal.
The recall is due to a manufacturing defect in PICC catheters containing valves that were manufactured prior to July 15, 2014. These specific units lack a manufacturing specification change that is designed to reduce the incidence of hemolysis, which is the breakdown of red blood cells, during blood sampling through the catheter.
The affected units were distributed worldwide, including nationwide 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. Specific batch/lot numbers and use-by dates are listed in the official recall documentation. Healthcare providers and patients should stop using the affected devices and contact Navilyst Medical for instructions on replacement or return.
The recalled product
- Product
- Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s
- Manufacturer
- Navilyst Medical, Inc., an AngioDyamics Company
- Category
- Medical Device — PICC Catheter
- Hazard
- Affected units
- 1,786
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) 4724924
- 4724925 & 4730412 with Use By 2016-03-31. Batch/Lots: 2) 4724929
- 4724923
- 4725426
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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