Recall Z-2555-2020 ยท FPA Set, Administration, Intravascular
CME America, LLC
BodyGuard Microset, REF: A100-163XESV
| Date | Jul 15, 2020 (initiated Jun 16, 2020) |
| Status | Terminated |
| Reason | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy |
| Root cause | Device Design |
| Action | On 06/16/20, Urgent Medical Device Recall Correction and Removal notices were emailed and mailed to customers and distributors. These notices provided additional information about the administration sets that were first identified in another recall notification issued on 04/27/20: www.bd.com/en-us/support/recall-notifications/recall-notification---cme-america-bodyguard-infusion-pump-system Customers ere asked to take the following immediate actions: 1) Share this letter with all users of the product within your facility to ensure awareness and understanding of this notice. 2) Identify any rema |
| Quantity | 178057 |
| Distribution | U.S: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT. OUS (Foreign): Canada, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042696 | BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd., Mar 11, 2005 |