Recall Z-1543-2024 ยท MRZ Accessories, Pump, Infusion
Smiths Medical ASD Inc.
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
| Date | Apr 15, 2024 (initiated Dec 19, 2023) |
| Status | Open, Classified |
| Reason | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded. |
| Root cause | Process control |
| Action | Smiths Medical issued an Updated UREGNT MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2023 via US mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: "Customer Required Actions - Medfusion Infusion Pumps: 1. Locate any affected Medfusion Syringe Pumps that may be in your possession by referring to the list of affected devices included with the Response Form. This list includes any specific pump model/serial number(s) your organization purchased that were manufactured or serviced with potentially affected Barrel Clamp Gu |
| Quantity | 1842 guide barrel clamps |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc., Aug 29, 2011 |