Drug recall
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA recall event 78835 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 78835 |
|---|---|
| Recall numbers | Z-0411-2018 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set… |
| Initiation date | Dec 21, 2017 |
| Report date | Jan 31, 2018 |
| Termination date | Aug 4, 2020 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 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: