Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.
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 potential for component detachment during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Navilyst Medical, Inc. (NMI) is recalling specific lots of Xcela and BioFlo PICC kits to the end-user level. The recall is based on information from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer included in these kits. Greatbatch Medical determined that the handles on the introducer sheaths have the potential to detach from the sheath during use.
NMI confirmed that the affected sheaths, identified by Greatbatch Model Number 10890-006, were included in packaged Xcela and BioFlo PICC Kits. The affected product is the Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, Catalog No. 45-895, Lot 4902618. A total of 4,591 units were distributed.
These products were distributed worldwide, including the United States (nationwide), Canada, Great Britain, the Netherlands, South Australia, and Spain. The 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 recalled product
- Product
- Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 4,591
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 (1)
- Lot 4902618
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) 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.
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