Z-0184-2024Class I

BD Alaris PCU REF 8015

Name: Z-0184-2024 BD Alaris PCU REF 8015
Creator: CareFusion 303, Inc.
Published: 2023-09-15
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-09-15 / Open, Classified / root cause: labeling and UDI

FDA source

CareFusion 303, Inc. began a recall of BD Alaris PCU REF 8015 on 2023-09-15. FDA classified it as Class I and gives the reason as "Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0184-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-15
Posted: 2023-11-07
Recalling firm: CareFusion 303, Inc
Product: BD Alaris PCU REF 8015
Product code: FRN Pump, Infusion
Reason for recall: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On September 15, 2023, CareFusion a subsidiary of Becton Dickinson (BD) posted an "Urgent Medical Device Labeling Correction" on their website. On October 4, 2023 CareFusion mailed a copy of the correction notification via FedEx. CareFusion asked consignees to take the following actions: 1. You should cease use of Cardinal Health branded Monoject" syringes with the BD Alaris" Syringe and PCA Modules; except for SKU 8881135609, which is not impacted by this notification. 2. Please refer to Attachments 1 and 2 of this notice for a full selection of syringes that are compatible with the BD Alaris" Syringe and PCA Modules. 3. Replace your current BD Alaris" Syringe and PCA Module Compatibility Lists with Attachments 1 and 2 of this notice. 4. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Alaris" Infusion System devices to. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787
Quantity in commerce: 867,362 units
Distribution: Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland
Product codes and lots: All Lots/ UDI DI: 10885403516030,10885403515316,10885403812033,10885403515286,10885403812026, 10885403515293,10885403494291,10885403515309,10885403812002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0184-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0184-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06
Z-0185-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06
Z-0186-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06

Product code FRN

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)