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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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 Class 2 Device Recall Covidien see related information
Date Posted February 18, 2016
Recall Status1 Open
Recall Number Z-0822-2016
Recall Event ID 72749
510(K)Number K111825 
Product Classification Staple, implantable - Product Code GDW
Product Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles

Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Code Information Kit Lot numbers:
00B0203
00Z1924
00Z1992
00Z1993
00Z2030
00Z2062
00Z2063
00Z2072
00Z2081
00Z2090
00Z2098
00Z2117
00Z2119
00Z2121
00Z2122
00Z2123
00Z2124
00Z2129
00Z2130
00Z2133
00Z2138
00Z2139
00Z2143
00Z2145
00Z2146
00Z2147
00Z2148
00Z2150
00Z2151
00Z2152
00Z2153
00Z2154
00Z2155
00Z2159
00Z2160
00Z2161
00Z2163
00Z2164
00Z2166
00Z2167
00Z2171
00Z2172
00Z2174
00Z2175
00Z2176
00Z2177
00Z2179
00Z2181
00Z2182
00Z2183
00Z2184
00Z2187
00Z2190
00Z2191
00Z2192
00Z2193
00Z2194
00Z2198
00Z2199
00Z2200
00Z2201
00Z2208
00Z2209
00Z2211
00Z2212
00Z2213
00Z2216
00Z2217
00Z2220
00Z2221
00Z2222
00Z2223
00Z2224
00Z2225
00Z2233
00Z2234
00Z2237
00Z2243
00Z2244
00Z2245
00Z2249
00Z2252
00Z2254
00Z2255
00Z2265
00Z2268
00Z2272
00Z2273
00Z2287
00Z2289
00Z2304
00Z2305
00Z2306
00Z2312
00Z2315
00Z2321
00Z2322
00Z2323
00Z2325
00Z2326
00Z2327
00Z2328
00Z2351
00Z2352
00Z2353
00Z2367
00Z2391
00Z2392
00Z2396
00Z2432
00Z5001
00Z5001A
BARIATRICRR1
BARIATRICRR5
BARIATRICRR7
ENDOBARIATRICR
ENDOBARIATRICS
ENDOTHORACICL
ENDOTHORACICS
ENDOTHORACICW
THORACICRR1
00Z2363
00Z2364
00Z2387
Recalling Firm/
Manufacturer
Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
FDA Determined
Cause 2
Process control
Action Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473. For questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 2711 kits
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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