Medfusion
67-2586-0100-01 is an electronic file. There is no packaging.
5manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K111386 |
| Record published | 2016-11-16 |
| Record revised | 2026-05-18 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Outer diameter 0 mm; length 0 mm; width 0 mm; circumference 0 mm; depth 0 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22-4075-0201-51 | In distribution | |
| 22-4095-0101-51 | In distribution | |
| 4000-0107-00 | In distribution | |
| 4000-0106-231 | In distribution | |
| 4000-0101-51 | In distribution | |
| 3000CAL | In distribution | |
| 67-2451-010501-51 | In distribution | |
| 4000-0107-231 | In distribution | |
| 67-2460-0003-51 | In distribution | |
| 67-2477-0600-01 | In distribution | |
| 22-0000-03 | In distribution | |
| 3500-0600-01 | In distribution | |
| 3500-500 | In distribution | |
| 22-4097-0101-51 | In distribution | |
| 4000-0105-249 | In distribution | |
| MFCC1 | In distribution | |
| 67-2449-0300-51 | In distribution | |
| 67-2586-0100-01 | Outer Diameter 0 mm | In distribution |
| 67-2450-010501-51 | In distribution | |
| 22-3510-51 | In distribution | |
| 3000RS232 | In distribution | |
| 4000-0107-01 | In distribution | |
| 3500-0600-82 | In distribution | |
| 3500-0600-78 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
| Plum | ICU Medical, Inc | 14 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242114 | 2025-04-02 |
| K242115 | 2025-04-02 |
| K223607 | 2023-08-24 |
| K052594 | 2006-02-10 |
Recalls Naming This Product
33 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class I | Software Design Change | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus | 93177 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class I | Software Design Change | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1 | 60146 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class II | Process control | 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 spr | 3821 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class II | Process control | 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 spr | 7160 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class II | Process control | 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 spr | 27 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-12-19 | Class II | Process control | 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 spr | 1842 guide barrel clamps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-08-16 | Class II | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will di | 20815 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-08-16 | Class II | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will di | 111 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-08-16 | Class II | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will di | 20383 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-08-16 | Class II | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will di | 67507 pumps | |
| Smiths Medical Asd, Inc. | 510(k) number | 2022-10-10 | Class II | Under Investigation by firm | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation | 422 devices | |
| Smiths Medical Asd, Inc. | 510(k) number | 2022-04-18 | Class I | Device Design | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) – Infusion Continues aft | 58671 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2022-04-18 | Class I | Device Design | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) – Infusion Continues aft | 65093 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-06-26 | Class I | Software design | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. | 35616 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-06-26 | Class I | Software design | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. | 17019 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2019-10-28 | Class I | Software design | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy. | 626 devices | 2024-06-06 |
| Smiths Medical Asd, Inc. | 510(k) number | 2018-04-13 | Class II | Process change control | 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. | 276 units | 2023-01-30 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-11-13 | Class II | Process change control | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) result | 16,600 pumps total | 2025-09-16 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-11-13 | Class II | Process change control | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) result | 16,600 pumps total | 2025-09-16 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-11-13 | Class II | Process change control | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) result | 16,600 pumps total | 2025-09-16 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-08-22 | Class II | Component design/selection | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump’s ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the “Invalid Syringe Size” alarm. | 9,787 units in total | 2025-04-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-08-22 | Class II | Component design/selection | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump’s ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the “Invalid Syringe Size” alarm. | 9,787 units in total | 2025-04-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2015-12-03 | Class II | Component change control | There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occu | 38,797 (31,065 pumps and 7,732 boards) | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Device Design | Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conduct | 9560 (8601 US, 959 OUS) | 2015-03-25 |
| Smiths Medical Asd, Inc. | 510(k) number | 2012-02-14 | Class I | Software design | Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audibl | 607 pumps (257 USA, 350 Canada) | 2012-11-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2012-01-02 | Not classified | Vendor change control | Pumps rendered inoperable at power up (displaying a blank screen and alarm). | 595 (WI )+ 864 (DC) = 1459 | 2013-07-25 |
| Smiths Medical Asd, Inc. | 510(k) number | 2010-06-22 | Not classified | Software design | Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run | 4816 | 2012-04-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2010-05-14 | Class II | Device Design | An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. | 6 | 2013-04-11 |
| Smiths Medical Asd, Inc. | 510(k) number | 2009-11-16 | Not classified | Device Design | Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high prio | 5393 | 2011-12-18 |
| Smiths Medical Asd, Inc. | 510(k) number | 2009-11-16 | Not classified | Device Design | Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high prio | 43 | 2011-12-18 |
| Smiths Medical MD, Inc. | 510(k) number | 2008-12-18 | Not classified | Nonconforming Material/Component | Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 (“Pump”) have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may | 957 | 2012-07-06 |
| Smiths Medical MD, Inc. | 510(k) number | 2008-12-18 | Not classified | Nonconforming Material/Component | Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 (“Pump”) have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may | 2552 | 2012-07-06 |
| Smiths Medical MD, Inc. | 510(k) number | 2007-02-03 | Not classified | Other | Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance Alarm goes off, preventing the pump from completing its pow | 23,519 | 2011-02-10 |
Recalls
9 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence.
Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-10 | Class II | Under Investigation by firm | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | 12525 units | |
| 2026-06-10 | Class II | Under Investigation by firm | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | 5059 units | |
| 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and | 86,113 | |
| 2026-04-29 | Class II | Software Design Change | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | 13,613 | |
| 2026-04-29 | Class II | Software Design Change | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | 13,613 | |
| 2026-04-29 | Class II | Software Design Change | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | 13,613 | |
| 2025-12-15 | Class II | Nonconforming Material/Component | ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide | 423 units | |
| 2025-12-15 | Class II | Software design | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy r | ||
| 2025-12-15 | Class II | Software design | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy r | ||
| 2025-12-15 | Class II | Software design | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy r | ||
| 2025-07-11 | Class I | Under Investigation by firm | ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. | 4677 units | |
| 2025-04-22 | Class II | Under Investigation by firm | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShi | 1701 units | |
| 2025-04-22 | Class II | Under Investigation by firm | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShi | 214 units | |
| 2024-10-22 | Class I | Nonconforming Material/Component | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same b | 3840 | |
| 2024-05-07 | Class I | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 11,961 units | |
| 2024-05-07 | Class I | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 130,826 units | |
| 2024-05-07 | Class I | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 14,744 units | |
| 2023-07-13 | Class II | Nonconforming Material/Component | Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. | 93135 devices | |
| 2023-03-22 | Class I | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 344 units | |
| 2023-03-22 | Class I | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 28656 units | |
| 2023-03-22 | Class I | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 23815 units | |
| 2023-03-22 | Class I | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expe | 9984 units | |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 2,327 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 6,516 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 4,600 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 32,416 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 14,850 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 73,710 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 26,700 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 51,250 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 6,400 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 5,443 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 1,536 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 521 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 155,150 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 170,735 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 400 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 280,826 units | 2024-01-12 |
| 2019-07-29 | Class II | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | 19,350 units | 2024-01-12 |
| 2018-08-01 | Class II | Software change control | A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface. | 47,152 devices | 2021-04-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.