Recall Z-2721-2020 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
| Date | Aug 6, 2020 (initiated Jun 30, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: 1.Inspect the IUI connectors on each PC unit and module prior to each use. DO NOT use a device with any damage, cracks, or surface contaminants (e.g., blue or green deposits, corrosion, cleaning residue deposition) on the IUI connectors, or with broken IUI connector pins. If damage, deposits, residue, or corrosion is noticed, take the device out of service and send the unit to Biomedical Engineering for re |
| Quantity | 38982 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |