ICU Medical
ESP-60cc version
5manufacturers in China registered for this device type
1catalogue number
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) | K914988 |
| Record published | 2021-10-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESP-60S | 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 |
| Medfusion | ICU Medical, 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 |
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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Excelsior Medical LLC | 510(k) number | 2006-03-21 | Not classified | Other | Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or s | 3911 units | 2006-12-07 |
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.