Recall
Class II — Maquet
| Recalling firm | MAQUET (Suzhou) Co., Ltd |
|---|---|
| Registered facility | MAQUET (SUZHOU) CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 55 kits were distributed after their expiration date of September 2015. |
| 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. |
| Quantity | 55 units |
| Distribution | Distributed to the states of NM, CA, and IL. |
| Initiated | 2017-05-22 |
| Classified | 2018-01-30 |
| Terminated | 2018-07-12 |
| Recall number | Z-0490-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet (Z-0490-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78765/
Not open yet
Alerts for MAQUET (Suzhou) Co., Ltd
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Planned
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.