Infusion Pumps

The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).

Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.

Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.

Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.

The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

A rare variant of TSH, identified in a small cluster of patients, is not detected.

It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.

A rare variant of TSH, identified in a small cluster of patients, is not detected.

A rare variant of TSH, identified in a small cluster of patients, is not detected.

It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.

A rare variant of TSH, identified in a small cluster of patients, is not detected.

The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.

A rare variant of TSH, identified in a small cluster of patients, is not detected.

The devices secondary audio signal fails to activate.

When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.

Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe

A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.

Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.

Microbiological identification media may exhibit reduced levels of Vancomycin.