PlainRecalls
FDA Devices Moderate Class II Terminated

Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500

Reported: August 29, 2012 Initiated: July 26, 2012 #Z-2233-2012

Product Description

Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500

Reason for Recall

Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu

Details

Units Affected
582 units
Distribution
Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
Location
Ann Arbor, MI

Frequently Asked Questions

What product was recalled? ▼
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 582 units.
Why was this product recalled? ▼
Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2233-2012.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →