Recall Z-2736-2015— Medtronic Perfusion Systems

Name: FDA recall Z-2736-2015
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 4 FDA 510(k) clearances: K122811, K012538, K891687 and 1 more. Product: MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. 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

4 on FDA's record

K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.·cleared 2012-10-12
K012538 — TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACEMedtronic Vascular·cleared 2001-08-23
K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc.·cleared 1989-05-31
K800178 — EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc.·cleared 1980-02-21

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

MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. 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.