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Terminated

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.

FDA Recall Z-0624-2016 · Posted 2016-01-08

Recalling FirmNipro Medical Corporation
Recall StatusTerminated
Product CodeFJK
Date Initiated2015-03-30
Date Terminated2016-02-04
Product Quantity1,484 pieces.

Reason for Recall

Blood foaming was found during evaluation of the product.

Firm Action

NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to [email protected] / 305.599.7174x249.

Root Cause

Device Design

Distribution Pattern

US Distribution to states of: TN and NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112628NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETNipro Medical Corporation · 2012-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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