Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk
Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheath handles 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 hazard involves a structural defect in a medical device (handle detachment) that poses a risk of injury during use, meeting the criteria for a Severe rating.
Plain-English summary
Navilyst Medical, Inc. (NMI) is conducting a recall of specific Xcela 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 have the potential to detach from the sheath during use.
NMI has confirmed that the affected sheaths, identified by Greatbatch Model Number 10890-006, were included in packaged Xcela and BioFlo PICC Kits. The affected products include the Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895, specifically Lot 4903458. A total of 4,591 units are involved in this recall.
The products were distributed worldwide, including nationwide in the United States, as well as in Canada, Great Britain, the Netherlands, South Australia, and Spain. Healthcare providers and facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
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
- 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 4903458
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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