CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report
BioFlo Hybrid PICC with Endexo and Pasv Valve Technology recalled
Navilyst Medical, Inc., an AngioDyamics is recalling BioFlo Hybrid PICC with Endexo and Pasv Valve Technology, Mst-70 Kit, 6F-, Upn H965458970, 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
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-1988-2016
- 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
- Labeling Errors
- Device type
- Patient Monitors
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
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 therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
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.
Questions about this recall
Is BioFlo Hybrid PICC with Endexo and Pasv Valve Technology, Mst-70 Kit, 6F-, Upn H965458970 recalled?
Yes. Navilyst Medical, Inc., an AngioDyamics recalled BioFlo Hybrid PICC with Endexo and Pasv Valve Technology, Mst-70 Kit, 6F-, Upn H965458970 on 14 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1988-2016.
Why was it 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.
Which lots are affected?
Batch/Lots: 4749414, 4766098, 4770315, 4776150 & 4790009. Use By Date Range 2016-05-31 to 2016-09-30
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Navilyst Medical, Inc., an AngioDyamics
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioFlo PICC with Endexo and Pasv Valve Technology recalled | Navilyst Medical, Inc., an AngioDyamics | Labeling Errors | Nationwide |
| Device | CLASS II | Vaxcel PICC with Pasv Kit under the following labels: 4F, Upn recalled | Navilyst Medical, Inc., an AngioDyamics | Other | Nationwide |
| Device | CLASS II | Xcela PICC with Pasv Valve Technology recalled | Navilyst Medical, Inc., an AngioDyamics | Labeling Errors | Nationwide |
| Device | CLASS II | Vaxcel PICC with Pasv Introducer Kit under the following recalled | Navilyst Medical, Inc., an AngioDyamics | Other | Nationwide |
| Device | CLASS II | BioFlo PICC with Endexo and Pasv Valve Technology recalled | Navilyst Medical, Inc., an AngioDyamics | Labeling Errors | Nationwide |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
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