Recall Z-0530-2021 ยท FRN Pump, Infusion
CME America, LLC
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical w
| Date | Jul 30, 2020 |
| Status | Terminated |
| Reason | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. |
| Root cause | Other |
| Action | On July 30, 2020, the firm sent an "URGENT MEDICAL DEVICE RECALL CORRECTION" Notification Letter via FedEx to customers informing them of two issues: Issue 1: The motor block mechanism may be affected over time by normal wear and tear which may cause the device to stop without alarms being generated. Issue 2: Due to routine cleaning and disinfection, there is a potential for fluid to ingress into the pump and over time, could result in damage to the pump components leading to inoperability of the device. For this issue the device will stop and will alarm. The Recalling Firm is instructing cu |
| Quantity | Total pumps = 4,182 (all models) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080954 | T34L SYRINGE DRIVER Caesarea Medical Electronics , Ltd., May 16, 2008 |