October 30, 2024Medical DevicesFDA
Diasol, Inc recalls Diasol Acid Concentrate REF G100325-10Dex 100
Hazard: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
October 30, 2024Medical DevicesFDA
Medtronic Neuromodulation recalls Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Hazard: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Hazard: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
October 30, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Hazard: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
October 30, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND
Hazard: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
October 30, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ223
Hazard: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.