CareFusion 303, Inc.
82 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for CareFusion 303, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-29FDA-DeviceClass IIBD Pyxis MedStation 4000 Main, REF 303
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- 2025-01-29FDA-DeviceClass IIBD Pyxis MedStation ES AUX, REF 324
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- 2025-01-29FDA-DeviceClass IIBD Pyxis MedStation ES (Med ES Main), REF 323
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- 2025-01-22FDA-DeviceClass IIBD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
- 2024-12-18FDA-DeviceClass IIBD Pyxis CII Safe ES, REF: 1116-00
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- 2024-12-18FDA-DeviceClass IIBD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- 2024-12-18FDA-DeviceClass IIBD Pyxis MedStation ES, REF: 323
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- 2024-09-25FDA-DeviceClass IIAlaris Pump Module Model 8100, a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- 2024-09-25FDA-DeviceClass IIAlaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- 2024-09-25FDA-DeviceClass IIAlaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- 2024-09-25FDA-DeviceClass IIAlaris PCA Module Model 8120, a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- 2024-09-25FDA-DeviceClass IIAlaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- 2024-09-11FDA-DeviceClass IIBKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- 2024-09-11FDA-DeviceClass IIBD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- 2024-08-14FDA-DeviceClass IIBD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
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