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Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. the legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development…

Smiths Medical identified legacy software anomalies which may occur in the Medfusion 4000 syringe infusion pumps. The legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development…

BD is issuing a notification to inform customers that Cardinal Health branded Monoject™ syringes have not been validated for use with the BD Alaris™ infusion devices. BD has validated Covidien branded Monoject™ syringes for use with the BD Alaris™…

BD is issuing a notification to inform customers that Cardinal Health branded Monoject™ syringes have not been validated for use with the BD Alaris™ infusion devices. BD has validated Covidien branded Monoject™ syringes for use with the BD Alaris™…

Epiphany, now a Baxter Healthcare company, is issuing an urgent medical device correction for the Cardio Server E3 ECG Management System Software due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used…

Cardinal Health Canada has been notified of an urgent product recall initiated by Ecolab for the equipment drapes, table cover, and surgical room turnover (SRT) kits. Ecolab as Microtek has received odor complaints on certain lots. The odor has been…

CHS initiated this recall after receiving a recall notification letter from Baxter which stated the following:  "This action is being taken as a precautionary measure as there may be a potential for the IV solution bags to leak at the connection…

Baxter Corporation is issuing an urgent medical device correction for a subset of novum Iq large volume pumps (LVP) due to reports of pump operators pressing a single key on the novum keypad, but the pump registers the intended key as well as incorrectly…

Baxter is issuing an urgent medical device correction for the Novum IQ Large Volume Pump (LVP) due to the potential for internal screws becoming loose and damaging the pumping mechanism valves.  Recall start date: July 26, 2023

Baxter Corporation is issuing an urgent medical device correction due to a defect in the Dose IQ Safety Software used with Novum IQ Large Volume Pump, resulting in an invalid initial setting for the air-in-line threshold for any new care area created in…

During the course of global market surveillance activities, the manufaturer has become aware of cases in which the resuscitaire infant radiant warmer with the optional scale could display inaccurate weight values. There is a potential for the mattress…

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Baxter is expanding the urgent medical…

During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27.…

Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Baxter…

Medline Industries, LP is recalling custom procedure packs containing medtronic non-absorbable sutures due to a manufacturing error in the packaging of the sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier…