FDA Device recall Z-1982-2016
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV,…
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV,… by Navilyst Medical An Angiodyamics, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1982-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-14 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Navilyst Medical An Angiodyamics |
| Distribution | US |
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, 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
Reason
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.
Identifiers
| code_info | Batch/Lots: 4732400, 4753201, 4776149, 4783743, 4797578, 4819459, 4830558 & 4836573. Use By Date Range 2016-05-31 to 2016-12-31. |
|---|
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-1982-2016%22
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