Nipro Medical Recalls Hemodialysis Blood Tubing Sets Due to Foaming
Nipro Medical Corporation is recalling 1,484 disposable hemodialysis blood tubing sets because blood foaming was found during product evaluation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used for extracorporeal blood access. The hazard of blood foaming poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nipro Medical Corporation is voluntarily recalling 1,484 pieces of the NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set. The recall is being conducted because blood foaming was identified during the evaluation of the product.
The affected products are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. They are compatible with Fresenius 2008H, 2008K/K2, and 2008T dialysis machines. The recall covers specific lots: 13E02, 13E03, 13E06, 13E07, 13E08, 13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.
The products were distributed in the United States to the states of Tennessee and New Jersey. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should stop using the affected lots and contact Nipro Medical Corporation for further instructions.
The recalled 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
- Manufacturer
- Nipro Medical Corporation
- Category
- Medical Device — Hemodialysis
- Hazard
- Affected units
- 1,484
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot #'s 13E02
- 13E03
- 13E06
- 13E07
- 13E08
- 13E09
- 13E10
- 13G03
- 13G11
- 13G15
- 14G24
- 13G30
- and 13H06.
Distribution
Related recalls
Same manufacturer · Nipro Medical Corporation
See all →- ModerateHemodialysis systems recalled because a screw may loosen or fall out
FDA (Devices) · 2025-12-17
- HighNipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion
FDA (Devices) · 2018-05-23
- LowNIPRO SafeTouch II Safety AVF Needle Recall for Torn Wings
FDA (Devices) · 2016-01-13
- ModerateNipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall
FDA (Devices) · 2015-11-04
- ModerateNIPRO Safe Touch Safety Scalp Vein Set Recalled for Potential Cracks
FDA (Devices) · 2014-06-25