Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Reported: August 12, 2020 Initiated: June 30, 2020 #Z-2722-2020
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.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 7854
- Distribution
- 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
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system. Recalled by CareFusion 303, Inc.. Units affected: 7854.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2020. Severity: Critical. Recall number: Z-2722-2020.
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