Food, drugs, devices › Nipro Medical Corporation
Device recall: NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline
Nipro Medical Corporation (Miami, FL) initiated this device recall on 30 Mar 2015; FDA lists 1 product record under event 72701, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 4 Feb 2016. Initiation: voluntary: firm initiated. Nipro Medical Corporation has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nipro Medical Corporation, Miami, FL.
Reason for recall
"Blood foaming was found during evaluation of the product."
Distribution
"US Distribution to states of: TN and NJ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0624-2016 | 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. | 1,484 pieces. | Class II | Terminated | 20 Jan 2016 |
Context
Other enforcement events for Nipro Medical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Oct 2025 | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | Device | Class II | 1 |
| 19 Dec 2017 | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines | Device | Class II | 1 |
| 13 Aug 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and f | Device | Class II | 1 |
| 1 Apr 2014 | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. | Device | Class III | 1 |
| 4 May 2013 | NIPRO Safe Touch Safety Scalp Vein Set | Device | Class II | 1 |
| 27 Jul 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in a | Device | Class II | 5 |
All 7 events for Nipro Medical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Blood foaming was found during evaluation of the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to states of: TN and NJ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.