Health product recall

Epix Grasper (2020-03-11)

Starting date:
March 11, 2020
Posting date:
April 17, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72813



Last updated: 2020-04-17

Affected Products

Epix Grasper

Reason

Southmedic Inc. Is conducting a voluntary recall of specific lot numbers of applied medical's Epix laparoscopic grasper, C4130 and C4140, and procedural packs containing these models, which includes K0880 laproscopic cholecystectomy kit and K2887 clip applier kit, due to the potential for tissue to catch on a slightly protruding rivet on the distal end of the device, which may lead to tissue damage.

Affected products

Epix Grasper

Lot or serial number

1364578

1371262

1373260

Model or catalog number

C4130

Companies
Manufacturer

Applied Medical Resources Corporation

22872 Avenida Empresa

Rancho Santa Margarita

92688

California

UNITED STATES