CLASS II Device recall · Reported 20 Jan 2016 · FDA Enforcement Report

Nipro Set / Slimline Blood Tubing Set for Hemodialysis recalled

Nipro Medical is recalling Nipro Set / Slimline Blood Tubing Set for Hemodialysis with Transducer Protectors and, distributed in New Jersey, Tennessee. The recall was initiated on 30 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.

Quantity recalled1,484 pieces.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0624-2016
FDA event ID: 72701
Recalling firm: Nipro Medical, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2015
FDA classified: 8 Jan 2016
Reported: 20 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Mar 2015	Recall initiated by company
8 Jan 2016	Classified by FDA	+284 days
20 Jan 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Blood foaming was found during evaluation of the product.

Product as listed by the FDA

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.

Where it was distributed

US Distribution to states of: TN and NJ.

New Jersey Tennessee

Questions about this recall

Why was it recalled?

Blood foaming was found during evaluation of the product.

Which lots are affected?

Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.

Where was it sold?

US Distribution to states of: TN and NJ.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nipro Medical

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17 Dec 2025Device	CLASS II	Hemodialysis System, Surdial DX recalled by Nipro Medical	Nipro Medical	Other	Nationwide
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13 Jan 2016Device	CLASS III	Nipro SafeTouch II Safety AVF Needle¿ inch recalled by Nipro Medical	Nipro Medical	Other	TN
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