Navilyst Medical Recalls Xcela and BioFlo PICC Kits
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that 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 3/5 (High).
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 mechanical failure (handle detachment) that could cause harm during use, but no injuries or illnesses have been reported.
Plain-English summary
Navilyst Medical, Inc. 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, which determined that the handles on certain sheaths have the potential to detach from the sheath during use.
Navilyst Medical confirmed that the affected Greatbatch Model Number 10890-006 sheaths were included in the packaged Xcela and BioFlo PICC kits. The affected products include the Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology. The recall affects 4,591 units distributed worldwide, including the United States, Canada, Great Britain, the Netherlands, South Australia, and Spain.
Healthcare providers and consumers should stop using the affected kits and contact Navilyst Medical for instructions on how to return the products. The recall is limited to Lot 4907223.
The recalled product
- Product
- Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 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 4907223
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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