Recall Z-1474-2020 ยท FRN Pump, Infusion
CME America, LLC
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
| Date | Mar 18, 2020 (initiated Jan 7, 2020) |
| Status | Terminated |
| Reason | Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h) |
| Root cause | Device Design |
| Action | On 01/07/20, Urgent Medical Device Correction notices were emailed to distributors and mailed to direct customers. For direct customers, Recommendation on further product use included: The recalling firm recommends that customers continue to use the infusion pump system as per intended use. 1. As per standard clinical practice, clinicians administering infusions should assess the fluid container for volumes infused, volumes remaining in the container at the end of the infusion and ensure the total volume of prescribed medication is delivered. 2. Verify your maintenance records to confirm you |
| Quantity | 30,596 pumps |
| Distribution | U.S.: HI, OR, AR, MA, PA, OH, WY, CO, NE, NC, WA, TX, UT, MD, CA, KY, FL, NH, TN, NY, SD, MO, IL, WI, MN, RI, VA, DC, SC, NJ, ME, KS, CT, MI, LA, AK, NM, IA, MT, ID, AZ, AL, VT, IN, MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM Caesarea Medical Electronics , Ltd., Aug 24, 2006 |