Medical Devices Recalls

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

There is a possibility of reagent leakage from the specimen container.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Includes an incorrect screw seat interface.