Device recall: Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Class I FDA enforcement event 85691. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
CareFusion 303, Inc. started this device recall on 30 Jun 2020. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class I. FDA event 85691 has 8 product records. The first FDA enforcement report date is 12 Aug 2020. The record gives the status Terminated, with the termination date 22 Apr 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
CareFusion 303, Inc., San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2716-2020 | Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system | 37141 | Class I | Terminated | 12 Aug 2020 |
| Z-2717-2020 | Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system | 824277 | Class I | Terminated | 12 Aug 2020 |
| Z-2718-2020 | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | 1332354 | Class I | Terminated | 12 Aug 2020 |
| Z-2719-2020 | Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system | 122423 | Class I | Terminated | 12 Aug 2020 |
| Z-2720-2020 | Alaris PCA Module Model 8120, a modular infusion pump and monitoring system | 83532 | Class I | Terminated | 12 Aug 2020 |
| Z-2721-2020 | Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system | 38982 | Class I | Terminated | 12 Aug 2020 |
| Z-2722-2020 | Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system | 7854 | Class I | Terminated | 12 Aug 2020 |
| Z-2723-2020 | Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system | 17767 | Class I | Terminated | 12 Aug 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class I
- 4%
- Product records in this event
- 8Median of the firm: 1
- Events of the firm on the register
- 99
Other events of the firm
Official channels
- FDA enforcement report Z-2716-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 85691. https://recallregister.com/fda/i/85691/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 85691?
- The event has 8 product records. The first record gives this quantity:
37141
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 4% of the 916 device events that started in 2020 are in Class I.