BD Alaris Syringe Module, REF 8110
Recall
- Recall Number
- Z-0185-2024
- Event Number
- 93106
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 15, 2023
- Posted
- November 7, 2023
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Alaris Syringe Module, REF 8110
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
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
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
133,727 units