RecallRadar

FDA Device recall Z-0624-2016

NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provid…

On 2016-01-20 the FDA classified a Class II recall of NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provid… by Nipro Medical, citing blood foaming was found during evaluation of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0624-2016
ClassificationClass II
Statusterminated
Initiated2015-03-30
Published2016-01-20
Last updated2026-09-13 11:54 UTC
CompanyNipro Medical
DistributionNJ, TN

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

Blood foaming was found during evaluation of the product.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0624-2016%22

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