Hemofiltration Standard Pack including BC 60 Plus-T 8036 — Class II medical device recall Z-0490-2018
Terminated recall by Maquet, reported 2018-02-07, distributed in CA, IL, NM. 55 kits were distributed after their expiration date of September 2015.
| Recall number | Z-0490-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet, Fairfield, NJ, United States |
| Recall initiated | 2017-05-22 |
| Classified | 2018-01-30 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-07-12 |
| Distributed | CA, IL, NM |
| Quantity | 55 units |
| UPC / GTIN / UDI-DI | 00607567206489 |
| Lot numbers | 3000001571 |
| Model numbers | 701066990 |
Product
Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for recall
55 kits were distributed after their expiration date of September 2015.
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-0490-2018. 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.