FDA Device recall Z-0709-2017
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:50…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:50… by Angiodynamics Navilyst Medical, citing medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0709-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-29 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO 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; for central venous pressure monitoring and for power injection of contrast media
Reason
Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.
Identifiers
| code_info | Batch/Lot: 1) 5018265, 2) 5024787, 3) 5021872, 4) 5020644, 5) 5026458, 6) 5026468 |
|---|
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-0709-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.