CLASS II Device recall · Reported 20 Dec 2017 · FDA Enforcement Report
Bio-Stable 5F DL- MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Bio-Stable 5F DL- MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, distributed nationwide in the US. The recall was initiated on 28 Nov 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-0251-2018
- FDA event ID
- 76570
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Nov 2016
- FDA classified
- 13 Dec 2017
- Reported
- 20 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 28 Nov 2016 | Recall initiated by company | |
| 13 Dec 2017 | Classified by FDA | +380 days |
| 20 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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 system for intravenous therapy, including but not limited to, the administration of fluids, medications, 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) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
Questions about this recall
Is Bio-Stable 5F DL- MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 recalled?
Yes. Angiodynamics Inc. (Navilyst Medical Inc.) recalled Bio-Stable 5F DL- MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 on 28 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0251-2018.
Why was it 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.
Which lots are affected?
Lot 4902618
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
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 Angiodynamics Inc. (Navilyst Medical Inc.)
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xcela PICC with Pasv Valve Technology/Kit 5 F recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | NY |
| Device | CLASS II | Smart Port CT-Implantable Port recalled by Angiodynamics Inc. (Navilyst | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | AngioDynamics Safe Sheath Ultralite recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | Starburst Talon Semi-Flex Electrosurgical Device recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | 5 states |
| Device | CLASS II | Bioflo 8f Single Plastic Non-filled recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Foreign Material | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |