Other Medical Devices

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.