Applied Medical Resources Corp: Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K

Hazard

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

Details from the source

Reason for recall: Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Den Quantity: 17,990 units Lot/code info: Reference Number/Lot Number/UDI Number: GK1003, AME KIT 54562 1493930 (01)20607915144979(17)250911(30)01(10)1493930 GK1003, AME KIT 54562 1499051 (01)20607915144979(17)251030(30)01(10)1499051 GK1003, AME KIT 54562 1505559 (01)20607915144979(17)251030(30)01(10)1505559 GK1003, AME KIT 54562 1509312 (01)20607915144979(17)260116(30)01(10)1509312 GK1003, AME KIT 54562 1510944 (01)20607915144979(17)260327(30)01(10)1510944 GK1004, KIT LAP CHOL DEN HOED 2 1498012 (01)20607915144993(17)251106(30)01(10)1498012 GK1004, KIT LAP CHOL DEN HOED 2 1498814 (01)20607915144993(17)251106(30)01(10)1498814 GK1004, KIT LAP CHOL DEN HOED 2 1507422 (01)20607915144993(17)250420(30)01(10)1507422 GK1004, KIT LAP CHOL DEN HOED 2 1510192 (01)20607915144993(17)260403(30)01(10)1510192 GK1005, K2550 - H¿PATECTOMIE ERASME 1503416 (01)20607915145006(17)251102(30)01(10)1503416 GK1011, K-19459 1492258 (01)20607915145136(17)240908(30)01(10)1492258 GK1011, K-19459 1494291 (01)20607915145136(17)240908(30)01(10)1494291 GK1011, K-19459 1496830 (01)20607915145136(17)240908(30)01(10)1496830 GK1011, K-19459 1501491 (01)20607915145136(17)240908(30)01(10)1501491 GK1011, K-19459 1503409 (01)20607915145136(17)241110(30)01(10)1503409 GK1011, K-19459 1505119 (01)20607915145136(17)241003(30)01(10)1505119 GK1011, K-19459 1506824 (01)20607915145136(17)250804(30)01(10)1506824 GK1011, K-19459 1509999 (01)20607915145136(17)250804(30)01(10)1509999 GK1011, K-19459 1512086 (01)20607915145136(17)260202(30)01(10)1512086 GK1014, K-18031

UPC codes

20607915144979, 20607915144993, 20607915145006, 20607915145136, 20607915145112, 20607915145211, 20607915145648, 20607915145723, 20607915145907, 20607915146188, 20607915146263, 20607915146348, 20607915146584, 20607915146959, 20607915147000, 20607915147376, 20607915136295, 20607915127279, 20607915139845, 20607915134864, 20607915134901, 20607915138725, 20607915139456, 20607915135592, 20607915139227, 20607915139036, 20607915140025, 20607915140032, 20607915140339, 20607915140841, 20607915127866, 20607915127873, 20607915139104, 20607915139746, 20607915139753, 20607915141275, 20607915141282, 20607915141305, 20607915141596, 20607915141602

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.