GAMBRO Capillary Dialyzer — Class II medical device recall Z-0370-2017
Terminated recall by Baxter Healthcare Corp., reported 2016-11-16, distributed nationwide. Potential presence of particulate matter on the blood side of the dialyzer
| Recall number | Z-0370-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-10-12 |
| Classified | 2016-11-08 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 22,656 units |
| Reason classes | specification failure |
Product
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Reason for recall
Potential presence of particulate matter on the blood side of the dialyzer
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-0370-2017. 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.