Drug recall
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA recall event 84693 · Class II · Custom Healthcare Systems, Inc.
Key facts
| Event ID | 84693 |
|---|---|
| Recall numbers | Z-0863-2020 |
| Recalling firm | Custom Healthcare Systems, Inc. |
| Product type | Devices |
| Products | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit… |
| Initiation date | Dec 20, 2019 |
| Report date | Feb 5, 2020 |
| Termination date | Aug 1, 2022 |
| City | Richmond |
| State | VA |
| Country | United States |
| FEI number | 1121091 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: