Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths have handles that may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a structural defect in a medical device where a component may detach during use, posing a risk of significant injury.
Plain-English summary
Navilyst Medical, Inc. (NMI) is recalling specific 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 has confirmed that the affected sheaths, identified as Greatbatch Model Number 10890-006, were included in the packaged Xcela and BioFlo PICC kits. The affected products include the Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology. These 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.
A total of 4,591 units are involved in this recall. The products were distributed nationwide in the United States and in Canada, Great Britain, the Netherlands, South Australia, and Spain. The specific lot number is 4906931. Users should contact Navilyst Medical for instructions on how to return or replace the affected kits.
The recalled product
- Product
- Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 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…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Kits
- 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 4906931
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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