Inzii 12/15mm retrieval system

Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy

Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System

101210001

MD: Tissue extraction bag

Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Applied Medical's Inzii¿ 12/15mm Retrieval System. || Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

Inzii 12/15mm Retrieval System (used as a receptacle for the collection and extraction of tissues, organs and calculi during laparoscopic procedures)Model Number: CD004Multiple lot numbers affectedManufactured from 20 January 2012 to 21 August 2013ARTG Number: 139393