—#203460

Product

BD Alaris PCU REF 8015

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051641, K072105, K133532, K211218
Affected lot / code info: All Lots/ UDI DI: 10885403516030,10885403515316,10885403812033,10885403515286,10885403812026, 10885403515293,10885403494291,10885403515309,10885403812002

Why it was recalled

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2023-09-15
Posted by FDA: 2023-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.