NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with… — Class II medical device recall Z-0624-2016
Terminated recall by Nipro Medical Corporation, reported 2016-01-20, distributed in NJ, TN. Blood foaming was found during evaluation of the product.
| Recall number | Z-0624-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Medical Corporation, Miami, FL, United States |
| Recall initiated | 2015-03-30 |
| Classified | 2016-01-08 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-02-04 |
| Distributed | NJ, TN |
| Quantity | 1,484 units |
| Lot numbers | 13E02, 13E03, 13E06, 13E07, 13E08, 13E09, 13E10, 13G03, 13G11, 13G15, 13G30, 13H06, 14G24 |
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.
Reason for recall
Blood foaming was found during evaluation of the product.
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-0624-2016. 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.