FDA (Devices) recall action 76570

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 13 products on 2017-12-20

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2017-12-20
Critical: 0
Units: 59,683

Why these products were recalled

Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

HighFDA (Devices)··2017-12-20
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.
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 fo
Category
Distribution
0 states
SevereFDA (Devices)··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 have handles that may detach during use.
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
Category
Distribution
0 states
SevereFDA (Devices)··2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included Greatbatch introducer sheaths have handles that may detach during use.
Product
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 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 syst
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment
Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.
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
Category
Distribution
0 states
SevereFDA (Devices)··2017-12-20
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.
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
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
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 sheath handles may detach during use.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 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
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
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 sheath handles may detach during use.
Product
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.
Product
Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 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 s
Category
Distribution
0 states
HighFDA (Devices)··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 introducer sheath handles may detach during use.
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
Category
Distribution
0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.
Product
XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 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
Category
Distribution
0 states
HighFDA (Devices)··2017-12-20
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 sheaths may have handles that detach during use.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 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
Category
Distribution
0 states
SevereFDA (Devices)··2017-12-20
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.
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 fo
Category
Distribution
0 states