Drug recall
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a…
FDA recall event 87150 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 87150 |
|---|---|
| Recall numbers | Z-1118-2021, Z-1119-2021, Z-1120-2021, Z-1121-2021, Z-1122-2021, Z-1123-2021 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems., Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery…, Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery…, Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis…, Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix… and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Initiation date | Dec 30, 2020 |
| Report date | Feb 24, 2021 |
| 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: