Recall Z-0186-2024 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PCA Module 8120
| Date | Nov 7, 2023 (initiated Sep 15, 2023) |
| Status | Open, Classified |
| Reason | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| 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 |
| Quantity | 86,393 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products, Oct 20, 2005 |
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX Cardinal Health 303,Inc., Dec 28, 2007 |
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc., Jul 21, 2023 |