APPLIED MEDICAL RESOURCES

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Failure of cardiovascular clips to provide sufficient occlusion of the vessel.

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

Due to possibility of insufficient sterilization.

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanis…

Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

Applied Medical is conducting a voluntary recall of the Inzii® 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur a…

Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix® and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in th…

Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The a…

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.