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The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

The packaging may not consistently maintain sterile barrier integrity.

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Transfemoral catheter, positing arm may detached due to weld issue.

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Reusable access port system may crack or seperate during use.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Reusable access port system may crack or seperate during use.

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Due to software malfunction, patient information system may freeze and become unresponsive.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.