Class 2 Device Recall Medfusion Model 4000 Syringe Pump

• Date Initiated by Firm: December 19, 2023
• Date Posted: April 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1541-2024
• Recall Event ID: 93771
• 510(K)Number: K111386
• Product Classification: Pump, infusion - Product Code FRN
• Product: Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: ; a) 4000-0101-249, ; b) 4000-0101-50, ; c) 4000-0101-51, ; d) 4000-0105-249, ; e) 4000-0105-50, ; f) 4000-0105-51, ; g) 4000-0105-78, ; h) 4000-0106-00, ; i) 4000-0106-01, ; j) 4000-0106-231,
• Code Information: All serial numbers Medfusion Model 3500 pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a) 4000-0101-249, UDI/DI 10610586040078, Serial Numbers: 2035426; b) 4000-0101-50, UDI/DI 10610586040054, Serial Numbers: 2033894; c) 4000-0101-51, UDI/DI 10610586040818, Serial Numbers: 2002706, 2004098, 2006133, 2006382, 2007411, 2008160, 2009040, 2009070, 2009661, 2009709, 2009723, 2009734, 2009997, 2010837, 2011049, 2011262, 2012096, 2013299, 2013805, 2020628, 2020630, 2020631, 2020972, 2023768, 2023983, 2023984, 2023985, 2024844, 2024913, 2024914, 2025040, 2026921, 2026922, 2026923, 2026924, 2026925, 2026926, 2026927, 2026928, 2026929, 2026930, 2026931, 2026934, 2026935, 2026936, 2026937, 2026938, 2026939, 2026940, 2026941, 2026942, 2026943, 2026944, 2026945, 2026946, 2026947, 2026948, 2026949, 2026950, 2026951, 2026952, 2026953, 2030198, 2031172, 2031173, 2032385, 2032622, 2034615, 2034616, 2034617, 2034618, 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2030672, 2030678, 2030681, 2030682, 2030684, 2030714, 2030715, 2030720, 2030744, 2030783, 2030788, 2030895, 2030896, 2030925, 2030927, 2030955, 2035670, 2035671, 2035672, 2035673, 2035674, 2035675, 2035676, 2035677, 2035678, 2035679, 2035680, 2035681, 2035682, 2035683, 2035684, 2035685, 2035686, 2035687, 2035688, 2035689, 2035690, 2035691, 2036026, 2036252, 2036253; g) 4000-0105-78, UDI/DI 10610586043574, Serial Numbers: 2026172, 2026433, 2032847, 2032881, 2033072, 2033132, 2035215, 2035443, 2035448, 2035454, 2035457, 2035458, 2035501, 2036239, 2036483, 2036494, 2036626; h) 4000-0106-00, UDI/DI 15019517070750, Serial Numbers: 2026144, 2026691, 2027396, 2032794, 2032811, 2032870, 2032889, 2032952, 2032957, 2032958, 2032992, 2033005, 2033065, 2033073, 2033123, 2033595, 2033596, 2033597, 2033598, 2035027, 2035028, 2035030, 2035032, 2035034, 2035037, 2035038, 2035424, 2035436, 2035463, 2035464, 2035478, 2035518, 2035540, 2035636, 2035669, 2036330, 2036378, 2036402, 2036478, 2036641, 2036671, 2036940, 2037084, 2037180, 2037234, 2037361, 2037472, 2037477, 2037523, 2037710, 2037828, 2037987, 2038016, 2038038; i) 4000-0106-01, UDI/DI 15019517069624, Serial Numbers: 2022965, 2026155, 2026242, 2026264, 2026274, 2026292, 2026293, 2026314, 2026373, 2026385, 2026404, 2026421, 2026932, 2026933, 2027025, 2027098, 2027163, 2027224, 2027225, 2027268, 2027331, 2027332, 2027333, 2027456, 2027459, 2027512, 2027594, 2027596, 2027601, 2027624, 2027674, 2027750, 2028841, 2029104, 2029133, 2030409, 2030418, 2030421, 2030435, 2030464, 2030466, 2030467, 2030492, 2030493, 2030500, 2030501, 2030509, 2030514, 2030522, 2030554, 2030560, 2030563, 2030573, 2030579, 2030580, 2030594, 2030599, 2030601, 2030606, 2030617, 2030621, 2030804, 2030805, 2030818, 2030824, 2030831, 2030846, 2030850, 2030858, 2030860, 2030865, 2030868, 2030882, 2030889, 2030991, 2030992, 2030997, 2031008, 2031010, 2031016, 2031021, 2031031, 2031040, 2031045, 2031065, 2031071, 2031095, 2031103, 2031119, 2031131, 2031134, 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2037949, 2037950, 2037951, 2037952, 2037953, 2037954, 2037955, 2037956, 2037957, 2037958, 2037959, 2037960, 2037961, 2037962, 2037963, 2037964, 2037965, 2037966, 2037967, 2037968, 2037969, 2037970, 2037971, 2037972, 2037973, 2037974, 2037975, 2037976, 2037977, 2037978, 2037979, 2037980, 2037981, 2037982, 2037983, 2037984, 2037985, 2037986, 2037988, 2037989, 2037990, 2037991, 2037992, 2037993, 2037994, 2037995, 2037996, 2037997, 2037998, 2037999, 2038000, 2038001, 2038002, 2038003, 2038004, 2038005, 2038006, 2038007, 2038008, 2038009, 2038010, 2038011, 2038012, 2038013, 2038014, 2038015, 2038017, 2038018, 2038019, 2038020, 2038021, 2038022, 2038023, 2038024, 2038025, 2038026, 2038027, 2038028, 2038029, 2038030, 2038031, 2038032, 2038033, 2038034, 2038035, 2038036, 2038037, 2038039; j) 4000-0106-231, UDI/DI 15019517070996, Serial Numbers: 2026690, 2035023, 2035024, 2035025, 2035026, 2035031, 2035033, 2035035, 2035036, 2036643
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: icumed.custhelp.com/app/market¿ action; 763-383-3072
• Manufacturer 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.
• FDA Determined 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 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
• Quantity in Commerce: 7160 pumps
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.