Z-2741-2020Class I

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

Name: Z-2741-2020 Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Creator: CareFusion 303, Inc.
Published: 2020-06-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-06-30 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of Alaris System PC Unit Model 8015. modular infusion pump and monitoring system on 2020-06-30. FDA classified it as Class I and gives the reason as "If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2741-2020
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-08-06
Terminated: 2024-04-22
Recalling firm: CareFusion 303, Inc
Product: Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Product code: FRN Pump, Infusion
Reason for recall: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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: This situation only occurs when the device is running on battery power. 1. If this issue occurs, immediately plug the PC unit into AC power and restart the infusions. 2. Obtain a replacement PC unit as soon as possible. 3. Ensure back-up devices are readily available when infusing critical medications. Please also ensure that you have back-up monitoring devices (e.g., EtCO2, SpO2) that are critically important to the patient's care. 4. Complete and return the Customer Response Card. Actions for Cleaning Personnel: Inspect all PC unit batteries for missing screws and washers during cleaning. Should missing screws or washers be identified, send PC unit to Biomedical Engineering for repair. Expedite the inspection of all PC unit batteries for loose or missing screws and washers. If loose or missing screws and washers are identified, please replace them and torque any loose screws or washers to 6 in/lb and perform battery conditioning. See Service Bulletin 592A. Contact recalling firm at 1-800- 482-4822 to order a package of screws and washers. Battery should be replaced every two years by qualified service personnel using authorized batteries. Actions by Recalling Firm: Battery Pack Assembly procedure was revised to add clarity for reassembly of the battery, including proper use of screws and washers. Updated Service Bulletin to be provided in August 2020. An initial quantity of replacement screws and washers will be provided for use. Future orders for replacement batteries will include screws and washers System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources/customer support: www.bd.com/alaris-system-hardware-recall Questions - Recall Support Center: 858-617-1316, GMB-Ala
Quantity in commerce: 824277
Distribution: U.S.: CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, KS, MN, MI, WA, UT, MD, TN, CO, NJ, NE, ND, WV, KY, IA, MS, AL, DE, AK, VA, OK, NM, GA, CT, SD, NV, ID, MT, ME, VT, WY, NH, MP, DC, GU, PR, AS, RI. O.U.S.: TR, QA, CA, AE, KW, MX, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, BH
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2741-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2740-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2741-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)