| Z-0001-2011 |
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Reason: The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of al
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2010-08-04 |
Terminated
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| Z-0002-2011 |
Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Reason: The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of al
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2010-08-04 |
Terminated
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| Z-0012-2013 |
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
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2012-09-07 |
Terminated
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| Z-0013-2013 |
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device;
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
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2012-09-07 |
Terminated
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| Z-0014-2013 |
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
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2012-09-07 |
Terminated
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| Z-0015-2013 |
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
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2012-09-07 |
Terminated
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| Z-0033-06 |
Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
Reason: If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.
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2005-06-16 |
Terminated
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