Device recall: Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550…
Class II FDA enforcement event 73598. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Navilyst Medical, Inc., an AngioDyamics Company started this device recall on 14 Mar 2016. The firm address in the FDA record is in Glens Falls, NY. FDA put the recall in Class II. FDA event 73598 has 23 product records. The first FDA enforcement report date is 22 Jun 2016. The record gives the status Terminated, with the termination date 11 Jun 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Recalling firm
Navilyst Medical, Inc., an AngioDyamics Company, Glens Falls, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
23 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1966-2016 | 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 administration of fluids including, but not… | 2,716 units | Class II | Terminated | 22 Jun 2016 |
| Z-1967-2016 | 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, but not limited to, hydration agents,… | 328 units | Class II | Terminated | 22 Jun 2016 |
| Z-1968-2016 | 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 administration of fluids including, but not… | 2,260 units | Class II | Terminated | 22 Jun 2016 |
| Z-1969-2016 | 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 system for administration of fluids… | 1,786 units | Class II | Terminated | 22 Jun 2016 |
| Z-1970-2016 | 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 venous system for administration of… | 5,566 units | Class II | Terminated | 22 Jun 2016 |
| Z-1971-2016 | 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 agents, antibiotics, chemotherapy,… | 210 | Class II | Terminated | 22 Jun 2016 |
| Z-1972-2016 | 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 fluids including, but not limited to,… | 1,127 units | Class II | Terminated | 22 Jun 2016 |
| Z-1973-2016 | 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 for intravenous therapy, including but… | 150 units | Class II | Terminated | 22 Jun 2016 |
| Z-1974-2016 | 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 for intravenous therapy, including but… | 105 units | Class II | Terminated | 22 Jun 2016 |
| Z-1975-2016 | 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 venous system for intravenous therapy,… | 568 units | Class II | Terminated | 22 Jun 2016 |
| Z-1976-2016 | 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 venous system for intravenous therapy,… | 55 units | Class II | Terminated | 22 Jun 2016 |
| Z-1977-2016 | 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 system for intravenous therapy,… | 2 units | Class II | Terminated | 22 Jun 2016 |
| Z-1978-2016 | 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 central venous system for intravenous… | 100 units | Class II | Terminated | 22 Jun 2016 |
| Z-1979-2016 | 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 central venous system for intravenous… | 157 units | Class II | Terminated | 22 Jun 2016 |
| Z-1980-2016 | 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 access to the central venous system for… | 357 units | Class II | Terminated | 22 Jun 2016 |
| Z-1981-2016 | 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 venous system for intravenous therapy,… | 60 units | Class II | Terminated | 22 Jun 2016 |
| Z-1982-2016 | 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 to the central venous system for… | 438 units | Class II | Terminated | 22 Jun 2016 |
| Z-1983-2016 | 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 to the central venous system for… | 376 units | Class II | Terminated | 22 Jun 2016 |
| Z-1984-2016 | 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 venous system for intravenous therapy,… | 2 units | Class II | Terminated | 22 Jun 2016 |
| Z-1985-2016 | 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 venous system for intravenous therapy,… | 445 units | Class II | Terminated | 22 Jun 2016 |
| Z-1986-2016 | 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 venous system for intravenous therapy,… | 10 units | Class II | Terminated | 22 Jun 2016 |
| Z-1987-2016 | 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 central venous system for intravenous… | 190 units | Class II | Terminated | 22 Jun 2016 |
| Z-1988-2016 | 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 central venous system for intravenous… | 275 units | Class II | Terminated | 22 Jun 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 23
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1966-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 73598. https://recallregister.com/fda/ii/73598/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
- What quantity of product is in FDA event 73598?
- The event has 23 product records. The first record gives this quantity:
2,716 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.