FDA Device recall Z-1227-2026
PRIMSAFLEX M100 SET, Product Code 106697
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of PRIMSAFLEX M100 SET, Product Code 106697 by Vantive Us Healthcare, citing there is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1227-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-06 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Vantive Us Healthcare |
| Distribution | US |
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Identifiers
| code_info | UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1227-2026%22
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