Every recall we track for ICU Medical, Inc. — 367 in all — plus the complaints and injury reports the public filed about them.
ICU Medical recalls specific lots of Hotline Fluid Warming Sets due to potential leakage. Affected units may cause fluid leaks during medical use. Contact for details.
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ICU Medical is a leading manufacturer of medical equipment and devices, specializing in critical care solutions for hospitals and healthcare facilities.
ICU Medical recalls Plum Solo Precision IV Pumps (40001-0401) due to potential under- or over-delivery of medications. Affected units may not alert clinicians of soft limit violations.
ICU Medical recalls Plum Duo Infusion Pump model 40002-0401 due to potential under- or over-delivery of medication. Affected units may not alert clinicians of soft limit violations.
ICU Medical recalls Plum Duo Precision IV Pumps (40002-0403) due to potential under- or over-delivery of medications. Affected units may not alert clinicians of soft limit violations.
ICU Medical recalls oncology kits with potential leaks during chemotherapy that could interrupt treatment and expose patients to hazardous substances. Affected kits include specific models and lots; contact for remedy.
ICU Medical recalls Portex Spinal Tray models A3729-24 and A3595 due to potential cracks in syringe collars causing blood leakage or repeated blood draws. Affected units include specific lots with UDI-DI numbers.
ICU Medical recalls specific Pulsator Arterial Blood Sampling Kits with possible cracks in syringe collars that could cause blood leakage or repeated blood draws during arterial sampling.
ICU Medical recalls Tego Connectors with specific model numbers due to risk of silicone seal bulging, tearing, leading to fluid leaks, blood product injection issues, or exposure to contaminants during hemodialysis.
ICU Medical recalls a specific lot of Plum Duo Infusion Systems that may fail to produce audible alarms, potentially causing missed alerts during medical use. Affected units have unique serial numbers listed in the recall notice.
ICU Medical recalls Plum Duo IV pumps with specific list numbers and software versions due to potential piggyback flush errors that may prevent proper flushing of IV lines.
ICU Medical recalls Plum Solo Precision IV Pumps with specific list numbers and software versions due to potential piggyback flush errors that may prevent proper flushing of IV lines.
ICU Medical recalls Plum Duo Infusion Pumps with specific list numbers and software versions due to potential flush errors during piggyback therapy that may prevent treatment. Affected units must be checked for error messages.
ICU Medical recalls LifeShield Drug Library Management software v2.2 due to concentration limit precision error. This may cause incorrect drug dosing if users adjust limits beyond manufacturer recommendations.
ICU Medical recalls LifeShield Drug Library Management v2.2.1 for migration issues that may cause infusion pump delivery errors. Affected users must use alternate methods to review changes after migration.
ICU Medical recalls 23" 150 mL IV burette sets with missing shutoff valve that could lead to over delivery or air infusion. Affected units include specific model numbers and serial ranges.
ICU Medical recalls ChemoLock Universal Vented Vial Spike REF CL-70 due to potential port weld separation causing leaks. Affected units have specific UDI and lot numbers.
ICU Medical recalls ChemoLock Vented Vial Spikes (CL-72) due to potential port weld separation causing drug leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
ICU Medical recalls 60" (152 cm) Appx 1.:2 ml Ext Set with potential port leak. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
ICU Medical recalls 1 unit of ChemoLock Bag Spike (REF: CL-10-1:10) due to potential port weld separation causing leaks during use. Affected units have specific UDI and lot numbers.
ICU Medical recalls ChemoLock Vented Vial Spikes (REF: CL-70S) due to potential port weld separation causing leaks during use. Affected units have specific UDI and lot numbers.
ICU Medical recalls ChemoLock Bag Spike with Clave Additive Port REF: CL394: Port weld may separate during use, causing leaks. Affected units have UDI 10887709095295 and lot 14406773.
ICU Medical recalls 7.5" (19 cm) Appx 1.5 ml sets with ChemoLock port that may leak if port weld breaks during use. Affected units sold in Canada.
ICU Medical recalls oncology kits with potential port leaks. Stop using if port weld may break during chemotherapy administration.
ICU Medical recalls ChemoLock w/Mini Bag Spike (Lot:1438522:14385224) in Canada due to potential port weld separation causing leaks. Affected users should contact for remedy.
ICU Medical recalls 73" (185 cm) Appx 2.5 ml Ext Set with ChemoLock Port due to potential port leak from weld separation during use. Affected units have UDI:10887709123356/Lot:14332784.
ICU Medical recalls 6" ext sets with ChemoLock port for potential leak if port weld breaks during use. Affected units sold in Canada.
ICU Medical recalls ChemoLock 13mm Closed Vial Spikes REF: CL-82 due to potential port weld separation causing leaks. Affected units have specific UDI and lot numbers.
ICU Medical recalls 31" admin sets with potential port weld leaks. Affected units sold in Canada; stop using immediately to prevent leaks.
ICU Medical recalls 8" ext sets with MicroClave Clear port that may leak if port weld breaks during use. Affected units sold in Canada with specific lot numbers.
ICU Medical recalls CL-80 ChemoLock Closed Vial Spikes due to potential port weld separation causing leaks. Affected units have UDI 1088770:14391976. Stop using immediately to prevent leaks.
ICU Medical recalls Oncology Kit with ChemoLock Port REF: CL4136 due to potential port weld separation causing leaks. Affected units have UDI:10887709096131/Lot:14393176.
ICU Medical recalls ChemoLock Bag Spike REF: CL-10 due to potential port weld separation causing leaks. Affected units have UDI 1088770:14419330. Stop using immediately to prevent drug leaks.
ICU Medical recalls 45" smallbore extension sets with potential port weld leaks. Affected units have specific model and lot numbers. Stop using immediately to prevent leaks.
ICU Medical recalls ChemosafeLock Bag Spikes with serial numbers 14399518-14406411 due to potential port weld separation causing leaks. Affected units distributed in Japan.
ICU Medical recalls Double ChemoLock Port Sy: CL-33 sets with potential leak risk from port weld separation. Affected units have specific UDI and lot numbers.
ICU Medical recalls oncology kits with potential port leaks. Affected kits may leak during use, causing drug exposure. Stop using immediately if you have the kit.
ICU Medical recalls ChemoLock Port REF: CL2100 with potential port weld leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
ICU Medical recalls Clave Bag Spike w/ChemoLock Port REF: CL215: Port weld may break during use, causing leaks. Stop using immediately.
ICU Medical recalls Graduated Connector with ChemoLock Port REF: CL3900 due to potential port leaks from weld separation during use. Affected units have specific UDI and lot numbers.
ICU Medical recalls ChemoLock Vial Spikes (REF: CL-80S) due to potential port weld separation causing leaks during use. Affected units have specific UDI and lot numbers.
ICU Medical recalls 30" admin sets with potential port leaks. Stop using if port may break during use.
ICU Medical recalls oncology transfer kits with ChemoClave and ChemoLock Port due to potential port leak from weld separation during use. Affected units have specific reference numbers.
ICU Medical recalls ChemosafeLock Vial Adapters with specific model numbers due to potential port weld separation causing leaks during use. Affected units sold in Japan.
ICU Medical recalls 30" admin sets with potential port weld leaks. Affected units have specific model and lot numbers. Stop using immediately to prevent leaks.
ICU Medical recalls 6.5" Bag Spike w/ChemoLock Port Additive Port (REF: CL3955) due to potential port leak from broken welds. Affected units have specific UDI and lot numbers.
ICU Medical recalls 21" Ext Set w/ChemoLock Port (REF: CL3360) due to potential port leaks from weld separation during use. Affected units have specific UDI and lot numbers.
ICU Medical recalls Chemo Lock Universal Vented V:10 vial spikes due to potential port weld separation causing drug leaks. Affected units have UDI 00887709070981 and lot 14380109.
ICU Medical recalls 20mm ChemoLock Vial Spikes due to potential port weld separation causing leaks. Affected units distributed in France with specific lot numbers.
ICU Medical recalls syringe transfer sets with ChemoLock Port REF CL-34 due to potential port leak from weld separation. Affected units distributed in Canada.
ICU Medical recalls ChemosafeLock Connecter REF KL-FNU3 with potential port weld leaks. Affected units distributed in Japan; stop using if leaks occur.
ICU Medical recalls ChemoLock Port, Bulk, Non-Sterile REF: CL2100-NS due to potential port weld separation causing drug leaks. Affected units have specific UDI and lot numbers.
ICU Medical recalls ChemoLock Port w/Spiros Red Cap REF: CL-35 due to potential port weld separation causing leaks. Affected units distributed in Canada.
ICU Medical recalls ChemoLock Closed Vial Spikes with potential port weld leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
Smiths Medical recalls certain 50mL and 100mL CADD medication cassette reservoirs that may leak medication due to weakened welds. Affected units have specific lot numbers and product codes.
Smiths Medical recalls certain CADD medication cassette reservoirs (50mL/100mL) that may leak medication due to weakened welds. Affected units have specific lot numbers and product codes.
Smiths Medical recalls certain CADD medication cassette reservoirs with weakened bag welds that may cause medication leakage. Affected units include specific lot numbers and product codes. Contact for remedy.
Smiths Medical recalls yellow-striped CADD medication reservoirs with potential medication leakage due to weakened welds. Affected units include specific lot numbers and product codes.
Smiths Medical recalls certain CADD 50mL and 100mL medication cassette reservoirs with weakened welds that could cause medication leakage. Affected units have specific lot numbers and product codes.
