Class II — Nipro Medical Corporation
| Recalling firm | NIPRO CORPORATION |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Blood foaming was found during evaluation of the product. |
| Product | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines. |
| Quantity | 1,484 pieces. |
| Distribution | US Distribution to states of: TN and NJ. |
| Initiated | 2015-03-30 |
| Classified | 2016-01-08 |
| Terminated | 2016-02-04 |
| Recall number | Z-0624-2016 |
| 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 — Nipro Medical Corporation (Z-0624-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72701/
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