CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
Peripherally Inserted Central Catheters (PICC), UPN H965750191 recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Peripherally Inserted Central Catheters (PICC), UPN H965750191, distributed nationwide in the US. The recall was initiated on 8 Jun 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-0715-2017
- FDA event ID
- 74948
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2016
- FDA classified
- 7 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jun 2016 | Recall initiated by company | |
| 7 Dec 2016 | Classified by FDA | +182 days |
| 14 Dec 2016 | 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
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Product as listed by the FDA
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The 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
Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
Nationwide CaliforniaFloridaGeorgiaHawaiiLouisianaMichiganMinnesotaMissouriNevadaOhioTexas
Questions about this recall
Why was it recalled?
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Which lots are affected?
Lot #: 4945781
Where was it sold?
Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
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
1 other product · FDA event 74948This product is part of a recall event; the main page for the event is Peripherally Inserted Central Catheters (PICC), UPN H965750141 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Peripherally Inserted Central Catheters (PICC), UPN H965750141 recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | Nationwide |
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.) | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |