FDA Device recall Z-2716-2020
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
- FDA Device
- Class I
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class I recall of Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system by Carefusion 303, citing 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 infu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2716-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-06-30 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
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.
Identifiers
| code_info | During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. ** US Serial numb…During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. ** US Serial numbers: 2326370, 2326382, 2326385, 2326387, 3668143, 2326400, 2326401, 2326402, 2326416, 2326418, 2326419, 2326423, 2326647, 2326664, 2326819, 2326821, 2326834, 2326837, 2326842, 2326873, 2326882, 2326883, 2326926, 9300064, 9300081, 9300083, 9300117, 9300149, 9300162, 9300163, 9300164, 9300171, 9300174, 9300176, 9300284, 9300302, 9300313, 9300317, 9300333, 9300334, 9300485, 3669844, 9300531, 9300532, 9300533, 9300534, 9300535, 9300538, 3686560, 4011408, 3696229, 3000933, 4122102, 4123517, 4123611, 4123651, 4123981, 4124350, 4124764, 4124999, 4125045, 4125149, 4125888, 4125923, 4126044, 4126051, 4126072, 4126073, 4126076, 4126077, 4126092, 4126093, 4126127, 4126128, 4126131, 4126146, 4126147, 4126148, 4126149, 4126151, 4126205, 4126206, 4126208, 4126212, 4126213, 4126214, 4126285, 4126286, 4126287, 4126288, 4126290, 4126299, 4126302, 4126315, 4126318, 4126358, 4126360, 41 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2716-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.