🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical
641 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps, Prescription Drugs, Implants & Prosthetics +1 more
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
🏥 Medical Devices Class I - Dangerous
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 LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
🏥 Medical Devices Class I - Dangerous
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 LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
🏥 Medical Devices Class I - Dangerous
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
🏥 Medical Devices Class I - Dangerous
Due to finished goods incorrectly packaged and labeled.
🏥 Medical Devices Class I - Dangerous
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 batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
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 expected.
🏥 Medical Devices Class I - Dangerous
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 expected.
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 expected.
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.
🏥 Medical Devices Class I - Dangerous
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 expected.
🏥 Medical Devices Class I - Dangerous
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 expected.
🏥 Medical Devices Class I - Dangerous
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 expected.
🏥 Medical Devices Class I - Dangerous
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 expected.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
💊 Drugs Class I - Dangerous
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Due to the incorrect filter assembly.