FDA (Devices) recall action 73598

Navilyst Medical, Inc., an AngioDyamics Company recalled 23 products on 2016-06-22

The FDA (Devices) publishes a recall like this one as 23 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 23 pages.

Products: 23
Announced: 2016-06-22
Critical: 0
Units: 17,283

Why these products were recalled

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

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.

States named across these recalls

1–23 of 23

ModerateFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo and Xcela PICC Catheters
Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central v
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 568 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of hemolysis during blood sampling.
Product
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology
Navilyst Medical is recalling 157 units of Xcela Hybrid PICC catheters because they lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 1,127 Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fl
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for admin
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology
Navilyst Medical is recalling 445 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central veno
Category
Distribution
1 state
ModerateFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 10 BioFlo Hybrid PICC catheter kits manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ven
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk During Blood Sampling
Navilyst Medical is recalling 210 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration age
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 438 BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access t
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk
Navilyst Medical is recalling 328 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including,
Category
Distribution
1 state
ModerateFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 150 units of Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.
Product
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cent
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 105 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system f
Category
Distribution
1 state
ModerateFDA (Devices)··2016-06-22
Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls Vaxcel PICC Catheters with PASV Valve
Navilyst Medical is recalling Vaxcel PICC catheters with PASV valves manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administ
Category
Distribution
1 state
SevereFDA (Devices)··2016-06-22
Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cen
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology
Navilyst Medical is recalling specific BioFlo Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.
Product
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cent
Category
Distribution
1 state
ModerateFDA (Devices)··2016-06-22
Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology
Navilyst Medical is recalling 376 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access t
Category
Distribution
1 state
HighFDA (Devices)··2016-06-22
Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela PICC catheters because they lack a manufacturing change that reduces the risk of hemolysis during blood sampling.
Product
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
Category
Distribution
1 state