Gambro Cartridge Low Volume Blood Transport System for Hemodialysis… — Class II medical device recall Z-2195-2020
Terminated recall by Baxter Healthcare Corporation, reported 2020-06-10, distributed nationwide. Potential disconnection of tubing set.
| Recall number | Z-2195-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-04-17 |
| Classified | 2020-06-01 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2023-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, DE, DK, EG, ES, FI, FR, GB, GR, HK, IL, IT, KR, KW, LT, LV, MA, NL, NO, PL, RS, RU, SE, SG, SI |
| Quantity | 19,800 units |
| Lot numbers | 1000201510, 1000206870, 1000214235, 1000218202, 1000224530 |
Product
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Reason for recall
Potential disconnection of tubing set.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2195-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.