Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included 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 conducting a recall of Xcela PICC with PASV, BioFlo PICC with PASV, and BioFlo PICC kits to the end-user level. The recall is based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer included in these kits.
Greatbatch Medical determined that the handles on the affected introducer sheaths (Model Number 10890-006) have the potential to detach from the sheath during use. NMI has confirmed that these specific sheaths were included in the packaged Xcela and BioFlo PICC kits.
The affected products are distributed worldwide, including the United States, Canada, Great Britain, the Netherlands, South Australia, and Spain. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 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 system for intrav
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Kits
- 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 4899431
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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