Infusion Pumps

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.

BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.

Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.

Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm

Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

Incorrect Power Supply in the package, rendering the device inoperable.

The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.

Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.

Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.

Revision of the field manual

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.