Infusion Pumps

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

QC process was not adequate for the specification range.

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

The QC process was not adequate for the specification range.

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Faceplate may become detached from the probe body.

A kit component, the PDI Prevantics Swab, was recalled.

Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

Pouch seals may be open, compromising sterility.

Pouch seals may be open, compromising sterility.

The product was stored incorrectly due to improper storage controls which may lead to delayed results.

Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.