Laparoscopic Accessories, Gynecologic

PS-500 Scope Warmer; 10 units per box.

Damage to package seals potentially compromising sterility.

Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140.

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 the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;

Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

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.

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

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.

DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620

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.

Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

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.

Clarke-Reich Laparoscopic Knot Pusher

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products