Other Medical Devices

CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.

Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Incomplete foil seal on one lot of sterile product.

The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.

Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.