CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report

Vaxcel PICC with Pasv Introducer Kit under the following recalled

Navilyst Medical, Inc., an AngioDyamics is recalling Vaxcel PICC with Pasv Introducer Kit under the following labels: 4F, Upn, distributed nationwide in the US. The recall was initiated on 14 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/Lots:1) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.

Quantity recalled328 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1967-2016
FDA event ID: 73598
Recalling firm: Navilyst Medical, Inc., an AngioDyamics, Glens Falls, NY
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2016
FDA classified: 14 Jun 2016
Reported: 22 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

14 Mar 2016	Recall initiated by company
14 Jun 2016	Classified by FDA	+92 days
22 Jun 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

Where it was distributed

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

Nationwide California Indiana

Questions about this recall

Why was it recalled?

Which lots are affected?

Batch/Lots:1) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.

Where was it sold?

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

22 other products · FDA event 73598

This product is part of a recall event; the main page for the event is Vaxcel PICC with Pasv Catheter Kit under the following recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Catheter Kit under the following recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela PICC with Pasv Valve Technology Catheter Kit, 6F recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Kit under the following labels: 3F, Upn recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Intermediate Safety Mst Kit under recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	BioFlo Hybrid PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela PICC with Pasv Valve Technology, Ir-145 Kit, 6F recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela PICC with Pasv Valve Technology, Mst-70 Kit, 6F recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela Hybrid PICC with Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela Hybrid PICC with Pasv Valve Technology, Catheter Kit recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Kit under the following labels: 4F, Upn recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	Xcela Hybrid PICC with Pasv Valve Technology, Ir-145 Kit recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	BioFlo Hybrid PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Xcela Hybrid PICC with Pasv Valve Technology, Mst-70 Kit recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	BioFlo Hybrid PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Introducer Kit under the following recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	Xcela PICC with Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016	CLASS II	Vaxcel PICC with Pasv Kit under the following labels: 4F, Upn recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide

More recalls from Navilyst Medical, Inc., an AngioDyamics

All 23

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016Device	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016Device	CLASS II	Vaxcel PICC with Pasv Kit under the following labels: 4F, Upn recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016Device	CLASS II	Xcela PICC with Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide
22 Jun 2016Device	CLASS II	Vaxcel PICC with Pasv Introducer Kit under the following recalled	Navilyst Medical, Inc., an AngioDyamics	Other	Nationwide
22 Jun 2016Device	CLASS II	BioFlo PICC with Endexo and Pasv Valve Technology recalled	Navilyst Medical, Inc., an AngioDyamics	Labeling Errors	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide