Z-2722-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7854
Product Description
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Reason for Recall
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Distribution Pattern
Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
Code Information
During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.