Terumo Interface Module for CDl System 500 Recalled for Malfunctions
Terumo is recalling Interface Modules for the CDl System 500 due to reported malfunctions involving loss of data transfer and smoke odor.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of smoke odor associated with malfunctions during critical medical procedures, which aligns with the rubric criteria for significant injury or property damage reports.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 582 units of the Interface Module for the CDl System 500. The module serves as the interface between the CDl 500 monitor and the system, communicating primary pump flow data and receiving blood parameter data.
The recall was initiated after the company received reports of malfunctions involving the loss of data transfer capabilities. Some reports indicated that the odor of smoke was associated with these failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modules.
The affected units were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Canada, Germany, and Japan. Affected units are identified by catalog number 803479 and specific serial number ranges. Users should contact Terumo Cardiovascular Systems Corporation for further instructions on the recall.
The recalled product
- Product
- 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 582
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- catalog number: 803479 and serial numbers:00009-00122
- 00124-00210
- 00213-00365
- 00367-00458
- and 00461-00596.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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