Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
This recall is currently active, issued April 15, 2024. It was issued by Smiths Medical Asd Inc..
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- December 19, 2023
- Posted
- April 15, 2024
- Recall Number
- Z-1542-2024
- Quantity
- 27 pumps
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution.
Lot / Code Info
All serial numbers for pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a. 3010, UDI/DI none, Serial Numbers: M03315, M03910; b. 3010A, UDI/DI 10610586032097, Serial Numbers: M04601, M05551, M05782, M06829, M07259, M07334, M07339, M07342, M07345, M07371, M08269, M08750, M08815, M10253, M10267, M10871, M10876, M10965, M11872, M11896, M11899, M11901, M11905, M11915; c. 3010E, UDI/DI none, Serial Numbers: M05179
Root Cause
Process control
Action Taken
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 Guides. Each pump has a unique serial number found on the label on the bottom of the pump. 2. You may continue to use the pumps but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until pumps containing potentially affected Barrel Clamp Guides are repaired. Customer Required Actions - Individually Sold Barrel Clamp Guides: 1. Locate any affected Barrel Clamp Guide (Part Number G6000716) lots in your parts inventory or within the Medfusion Syringe Pump(s) you have repaired at your facility. NOTE - If you have purchased affected individually sold Barrel Clamp Guides, the Response Form included with this notice will indicate the order numbers shipped to your organization and a Return Label will be provided. 2. If any potentially affected Barrel Clamp Guides have already been installed in pumps, you may continue to use the pumps, but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until the pumps installed with potentially affected Barrel Clamp Guides are repaired. If you have affected devices, please contact Smiths Medical for repair of the pump." "DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Ask them to c