Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths have handles that may detach during use.
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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
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. This action was taken after Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer included in these kits, determined that the handles on the sheaths have the potential to detach from the sheath during use.
NMI confirmed that the affected sheaths, identified as Greatbatch Model Number 10890-006, were included in the packaged Xcela and BioFlo PICC kits. The recall affects 4,591 units in total, which were distributed nationwide in the United States and in Canada, Great Britain, the Netherlands, South Australia, and Spain.
Healthcare providers and end users should stop using the affected kits and contact Navilyst Medical for instructions on how to return the products or obtain replacements.
The recalled product
- Product
- XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 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 Lines
- 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 4903452
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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