The Recall Desk
HighFDA (Devices)·Z-0248-2018·Announced 2017-12-20

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 may have handles that 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, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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 involves the Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883, Lot 4908978. A total of 4,591 units are affected. These products 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.

The recall was initiated based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. 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 confirmed that these specific sheaths were included in the packaged Xcela and BioFlo PICC kits.

The affected products were distributed worldwide, including the United States (nationwide), 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 further instructions.

The recalled product

Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 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
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 4908978

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.

See all 13 products in this recall →

Related recalls

Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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Same hazard · component detachment

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