Recall Z-2735-2015— Medtronic Perfusion Systems

Name: FDA recall Z-2735-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-18

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2015-08-18, terminated 2016-05-09. It names 2 FDA 510(k) clearances: K983085, K923139. Product: MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.. Reason: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2015-08-18
Terminated: 2016-05-09
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K983085 — HEMOCOR HPH 700 HEMOCONCENTRATORMinntech Corp.·cleared 1998-11-13
K923139 — HEMOCOR HP HEMOCONCENTRATOR SERIESMinntech Corp.·cleared 1994-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.

Reason for recall

Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

Data sourced from openFDA. This site is unofficial and independent of the FDA.