Z-2718-2020 Class I Terminated
FDA device recall Z-2718-2020 was initiated by CareFusion 303, Inc. on Jun 30, 2020 and is designated Class I. 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… The recall status is terminated (terminated Apr 22, 2024). Affected quantity: 1332354.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 12, 2020
- Initiation Date
- Jun 30, 2020
- Termination Date
- Apr 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1332354
Product Description
Alaris Pump Module Model 8100, 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2718-2020
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026