PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
USPRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recalling Firm: VANTIVE US HEALTHCARE LLC
Reason for Recall / Hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Product Description & Identification
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Additional Source Details
| Field | Value |
|---|---|
| City | Deerfield |
| State | IL |
| Event id | 98180 |
| Address 1 | 510 Lake Cook Rd |
| Address 2 | N/A |
| Code info | UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA |
| Postal code | 60015-4964 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 230,596 units |
| Reason for recall | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260106 |
| Initial firm notification | Letter |
| Center classification date | 20260202 |
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Overview
- Recalling FirmVANTIVE US HEALTHCARE LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: VANTIVE US HEALTHCARE LLC - PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System Check if your household is affected: https://therecallfile.com/recalls/primsaflex-m100-set-product-code-106697-dialyzer-high-permeability-wit/FDA-Z-1227-2026
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