CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report

Nipro Blood Tubing set with Priming Set and Transducer Protectors recalled

Nipro Medical is recalling Nipro Blood Tubing set with Priming Set and Transducer Protectors, distributed in Georgia, New York, Tennessee, Texas. The recall was initiated on 19 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.

Quantity recalled307,944 units.

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-1876-2018
FDA event ID: 79834
Recalling firm: Nipro Medical, Doral, FL
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2017
FDA classified: 15 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

19 Dec 2017	Recall initiated by company
15 May 2018	Classified by FDA	+147 days
23 May 2018	Published in enforcement report	+8 days

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

Reason for recall

There is a possibility of the heparin line is occluded.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

Where it was distributed

US Distribution to the states of : GA, NY, TN, TX.

Georgia New York Tennessee Texas

Questions about this recall

Why was it recalled?

There is a possibility of the heparin line is occluded.

Which lots are affected?

Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.

Where was it sold?

US Distribution to the states of : GA, NY, TN, TX.

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 21 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

All 11

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Device	CLASS II	Hemodialysis System, Surdial DX recalled by Nipro Medical	Nipro Medical	Other	Nationwide
20 Jan 2016Device	CLASS II	Nipro Set / Slimline Blood Tubing Set for Hemodialysis recalled	Nipro Medical	Other	NJ, TN
13 Jan 2016Device	CLASS III	Nipro SafeTouch II Safety AVF Needle¿ inch recalled by Nipro Medical	Nipro Medical	Other	TN
4 Nov 2015Device	CLASS II	Nipro Safe Touch Tulip Safety Fistula Needle, FT+152530TP recalled	Nipro Medical	Packaging Defects	IN
25 Jun 2014Device	CLASS II	Nipro Safe Touch Safety Scalp Vein Set recalled by Nipro Medical	Nipro Medical	Packaging Defects	FL

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