Recall Z-2662-2018 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
| Date | Apr 13, 2018 |
| Status | Terminated |
| Reason | Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe. |
| Root cause | Process change control |
| Action | Customers were notified of the recall on about 04/13/2018 via URGENT MEDICAL DEVICE RECALL NOTICE letter. Instructions included to evaluate current inventory for affected Barrel Clamp Guide, review and complete the Recall Response Form, return affected Barrel Clamp Guides to Stericycle for destruction, and if the affected Barrel Clamp Guides have already been installed in pumps, continue to use the pumps, but utilize the Syringe Verification Reference Tool provided with the Recall Notice until the pumps are repaired. Customers were also instructed to notify customers if the affected devices |
| Quantity | 276 units |
| Distribution | US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon. |
| FDA record | Open on fda.gov |