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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris PCU (pump control unit)

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  Class 1 Device Recall Alaris PCU (pump control unit) see related information
Date Initiated by Firm September 15, 2023
Date Posted November 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0184-2024
Recall Event ID 93106
510(K)Number K072105  K051641  K211218  K133532  
Product Classification Pump, infusion - Product Code FRN
Product BD Alaris PCU REF 8015
Code Information All Lots/ UDI DI: 10885403516030,10885403515316,10885403812033,10885403515286,10885403812026, 10885403515293,10885403494291,10885403515309,10885403812002
Recalling Firm/
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact BD Support Center
Manufacturer Reason
for Recall
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH 303, INC.
510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
510(K)s with Product Code = FRN and Original Applicant = CareFusion 303 Inc.
510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.