FDA Device recall Z-0715-2017
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenien…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenien… by Angiodynamics Navilyst Medical, citing 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) measur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0715-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-08 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot #: 4945781 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0715-2017%22
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