Medical device recalls

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.