Medical device recalls

Product packaging may not be completely sealed.

The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.

if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.

Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client.

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.

The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.

When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.

We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).

Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.

The concentration of bromocresol purple in the recalled lots does not conform to specification.

The concentration of bromocresol purple in the recalled lots does not conform to specification.

This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.

The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.