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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 49060
Product Type Devices
Status Completed
Recalling Firm SRI Surgical
City Tampa
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-07-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages. Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS0880D GS0880E GS0880F LD0994D LD1000A GS0983C LD1019A LD1019B LD1029A OR0986B OR0986C OR0986D GS0935B-M GY1223 GY1223A CY1028C CY1028D ET1023A ET1023B ET1023C ET1023D EY1024A EY1024B EY1024C EY1024D EY1024E GS0764D GS0764E GS0780D GS0780E GS1219 LD1022B LD1022C LD1022D LD1132 LD1132A LD1132B OR1025A GS1043 GS1044 GS0937D GS0937E GS0938B GS0938C GS0995 GS0995A GS0995B GS0995C GY0996 HT0980A HT0980B HT0980C HT0987B HT0987C HT1128 NU0939C NU0939D GS1136 GS1136A GS1136B CL1035 CL1035A CL1035B NU0700G ET1243 ET1243A EY1242 GS1200A GS1245 GS1245B GS1248 GS1248A GS1285 GS1285A GS1285B HT1247 HT1247A HT1247B NU1249 NU1249A NU1249B NU1249C OR1196B OR1244 OR1244A OR1244B OR1244C OR1246 OR1246A OR1246B CL0705F CL0705G CL0705H EY0696E HT0482E HT0482F HT0482G HT1228 HT1234A-M HT1234B-M HT1234D-M HT1234E-M HT1234F-M HT1234-M LD0693F LD0693G LD0694C NU0700I NU1157 NU1157A GS1268 GS1268A GS1268C GS1287 GS1287A GS1287B GF1333 GF1333A OR1340 CV0691G CV0691H CY0695G CY0695H CY0695I ED0704K ED0704L ED0704M EY0707F EY0707G GS0689A GS0689C GS0692I GS0692J GS0692K GS0692L GS0697E GS1074 GS1074A GS1074B HT0482I HT0482J HT0482K HT0706B HT0706C NU0690H NU0690I NU0690J NU0690K NU0690L NU0699I NU0699J NU0699K NU0700H OR0698F OR0698G OR0698H OR0925A GS1146 GS1146A GS1147 GY1151 GY1151A OR1148 OR1149 OR1149A OR1150 GS0891C GS0891D CV1186 CV1186A CV1199 ET1197 ET1197A EY1154 EY1183 EY1183A EY1183B EY1183C GS1185 GS1191 GS1193 GS1193A GS1194 GS1194A GS1195 GS1198 GS1200 HT1182 HT1182A HT1182B-M HT1182D LD1301B LD1303 NU1190 NU1190A NU1192 OR1184 OR1184A OR1187 OR1188 OR1188A OR1188B OR1189 OR1196 OR1196A OR1196B OR1263 CL0753C-M CL0753D-M CL0753E CL0753F CL1215 CL1215A CL1215B HT0756H HT0756I HT0756J CL0753G CL0753H CL0753I CL1215A HT0756K BS1209 BS1209A BS1209B CL1253 CL1253A CV1068 CV1069 CY1078 CY1078A CY1078B CY1078C ET1076A ET1076B ET1076C ET1079 ET1079A ET1080A ET1080B EY1077 EY1077A EY1077B GS1061A GS1061B GS1088 HT1252 HT1252A OR1062 OR1062A OR1063A OR1063B OR1065A OR1089A OR1251 OR1257 CV0773F CV0773G GY0957D GY0957E LD0771C LD0772F LD0772G OR0777E OR0777F OR0777G OR0929B OR0929C OR0929D HT0283I ET0222J ET0222K EY0224I EY0224J GS0223I GS0223J GS0506G CV1175 CY1172 ET1109C ET1177 GS1129A GS1169-M GS1170 GS1174 GY0969C GY1164 GY1165 GY1171 GY1176 GY1176A GY1176B GY1218 NU1178 OR1111B OR1112A OR1112B OR1112C OR1114 OR1131 OR1167 OR1168 OR1205 OR1206 OR1216 OR1217 GS1169A GS1170A NU1120E OR1112E OR1167A OR1072A OR1072B OR1072C OR1073A OR1073B OR1073C OR1073D OR1075C OR1075D OR1075E OR1075F OR1075G HT0283J OR1057A OR1138 GS1259-A GS1259-B GS1265-A GS1265A-A HT1313 CL1161 CL1162 CL1163 ET1109 ET1109B ET1109D ET1109E ET1110 ET1110A GS0521E GS1115 GS1115A GS1115B GS1115C GS1124 GS1124C GS1124D GS1124E GS1124F GS1124G GS1125 GS1125A GS1125B GS1125C GS1129 GS1129B GS1139 GS1181 GS1181A GS1181B GY1165A NU1119B NU1120 NU1120A NU1120B NU1120C NU1120D NU1122 NU1122A NU1122B NU1122C OR0432E OR0480E OR0480F OR0480G OR0480H OR0715I OR0715K OR0715L OR1111 OR1111A OR1111C OR1111D OR1112 OR1112D OR1113 OR1114A OR1126 OR1126B OR1126C OR1126D OR1126F OR1202 OR1202A OR1229 PL1123 PL1123A PL1123B PL1123C CL1293 CL1293B CL1293C CL1293D CL1294 CL1294A CL1294B HT1283 HT1283A HT1283B HT1283C GS1030A GS1030B GS1335 GS1335A ET1255 ET1255A ET1256 GS1254 GS1254B GS1261 GS1261A GS1291 GS1291A GS1291B GS1291C GY1308 LD0536G LD0570F LD0916D LD1260 LD1260A LD1260B LD1260C LD1262 LD1262A LD1262B OR1275 OR1275B OR1275C OR1275D OR1275E GS1264 GS1231 GS1231A GS1231B GS1231C GS1232 GS1232A GS1232B GS1232C OR1233 OR1233B PL1230 PL1230A PL1230B PL1230C OR0483E GS1173 GS1173A EY1258 EY1258B EY1258C OR0972D OR0972E OR0973C OR0973D GS1026A GS1026B GS1027A GS1030C GS1031A-M GS1031B CL1018G CL1018H CL1018I CV1011-M CV1070 GS1012-M GS1013-M GS1014-M GS1053 HT1015B-M HT1015C-M HT1016A-M HT1017 ET1212 ET1212A-M ET1212B-M ET1212C-M PL1211 PL1211A-M PL1237 PL1237A GS1153 HT0768D OR0710C GS0788E-M GS0788F-M ET0837F EY0787G GS0959B GS0971B HT0932 HT0932A LD0680C LD0838F NU0685E OR0681D GS1040 GS1040A CV0597H GS0471E HT0456G HT0456H HT0456I HT0456J HT0456K HT0456L-M HT0456M-M HT0456N NU0430J NU0430K NU0430L NU0436K NU0436L NU0436M OR0431H OR0431I OR0431J OR0431K OR0432F OR0432G OR0432H BS0507C BS0679A CL0525H CL0525I CL0525J CL0525K CL0537H CL0537I CL0537J CL0537K CL0537L CL0537N CL0578C CL0578D CL0578E CL0647B CL0647C CL0952C-M CL0952D-M CL0962H CL0962I CL0962J CL0962L CV0527E-M CV0527F-M CV0527G CV0582E CV0582F CV0582G CY0567E CY0567F ET0513J-M ET0513K-M ET0514E-M ET0514F-M ET0577B ET0577C ET1042 EY0511D EY0515F EY0515G GS0517H-M GS0517I GS0519C-M GS0522B GS0522C GS0523I GS0523J-M GS0523K-M GS0528I-M GS0528J-M GS0528K-M GS0528L-M GS0528M-M GS0533B GS0533C GS0533D GS0553E GS0553F GS0553G GS0579F GS0579G GS0579H GS0631E-M GS0631F-M GS0803C GS0804C GS0806F GS0948D GS0948E GS0948F GS1003D GS1003E GS1004A GS1201 GY0534F GY0534G GY0568D GY0568E GY0569D GY0569F HT0540C HT0584M HT0584N HT0584O HT0584P HT0585B LD0536C LD0536D LD0536E LD0536F LD0570E LD0808E NU0512C NU0538C NU0538D NU0539D NU0539E NU0544H NU0544I NU0544J NU0544J-M NU0544K-M NU0544L-M NU0544M-M NU0546H NU0561G NU0561H NU0581D NU0784C-M NU0784D-M NU0807D NU0940C-M OR0510D-M OR0520G OR0524C OR0524D OR0524D-M OR0526E OR0526F-M OR0532E OR0551F OR0558E OR0558F OR0572B OR0574C OR0574D OR0574E OR0574F OR0574G OR0673C OR0673D OR0805D OR0984 OR0991C OR0992B OR0992C OR0993A OR1054 OR1054A OR1135 OR1135A LD0965B LD0965C LD0966B OR0964A OR0967A GS0654D CL0621C CL0926E CL1299 CL1299A CV0605E CV0605F CV0605G CV1006A CV1006B CV1006C CV1006D EY0598F EY0598G GF0670C GF0670D GF0670E GS0600G GS0600H GS0601D GS0601E GS0654C GS1314 HT0611I HT0611J HT0611K HT0611L HT1343A NU0618G NU0618H NU0618I OR0604G OR0604H OR0619E OR0619F OR0619G OR0885G OR0885H OR0885I CL0926B CL0926C CL0926D CL0926G GF1056 GS1071A-M GS1071B-M GS1071C-M GS1071-M OR0883F OR0883G OR0936C GS0844C GS0893C GS0978 GS0978A GY0923C BS0852D BS0852E CL0881E CL0881F CL0881G CL0881H CL0881I CL1286 CV0853D CV0853E CV0853F CV0853G CV0853H CV0854C CV0854D CV0854E CV0855D CV0855E CV0855F CV0855G CV0855H ET0856G ET0856H ET0856I ET0857E ET0857F ET0857G ET0857H ET0857I ET0857J ET0857K ET0857L ET0858G-M ET0858H ET0858I ET0858J ET0858K GF1055B GF1055C GF1055D GF1055E GS0859D GS0859E GS0859F GS0859G GS0859H GS0876B GS0876C GS0876E GS0876F GS1220 GS1300 GY0860E GY0860F HT0861F HT0861H HT0862G HT0862H HT0862I HT0862J HT0863E HT0863F HT0863G HT0863H HT0863I LD0864E LD0864F LD0864G LD0864H LD0864I NU0865E NU0865F NU0865G NU0865H NU0866E NU0866F NU0866G NU0866H NU0867G NU0867H NU0867I NU0867J NU0868E NU0868F NU0869D NU0869E NU0869F OR0870C OR0870D OR0870E OR0871C OR0871D OR0871E OR0871F OR0871G OR0871H OR0871I OR0872A OR0874B OR0874C OR0874D OR0874E PL0875E PL0875F PL0875G PL1306 ET1144 GS1143 GS1143A CL0139M CL0139N GS0056M GY1021 GS1037A LD0832F LD1145A LD1145B LD1145C LD1145D LD1159 LD1159A LD1159B GS0833B CL1033 CL1033A CL1033B CL1034C CL1315 CV0734H CV0734I CV0734J CV0734K CV0734L CY0714B CY0714C CY0714D CY0714E CY0736J CY0736K CY0736L CY0736M CY0736N ET0722K ET0722L ET0722M ET0722N ET0722O ET0722P ET0731L ET0731M ET0731N ET0731O ET0731P ET0731Q ET0731R ET0731S ET0731T ET0733G ET0733H ET0733I ET0733J ET0979B ET0979C ET0979D ET0979E EY0720H EY0720I EY0720J EY0720K EY0724H EY0724I EY0724J GS0712J-M GS0712K GS0712L GS0725H GS0725I GS0725J GS0725K GS0725L GS0725M GS0727J GS0727K GS0727L GS0727M GS0727N GS0727O GS0727P GS0728I GS0728J GS0728K GS0728L GS0728N GS0728O GS0735J GS0735K GS0735L GS0735M GS0735N GS0737I GS0737J GS0960D GS0960E GS0960F GS1334 HT0711L-M HT0711M HT0711N HT0711O HT0711P HT1047 HT1047A HT1047B LD0729M LD0729N LD0729O LD0729P LD0729Q LD1032B LD1032C LD1298 NU0723G NU0723H NU0723I NU0723J OR0715J OR0715M OR0715N OR0715O OR0716H OR0716I OR0716J OR0716K OR0716L OR0716M OR0716N OR0717G OR0717H OR0717I OR0717J OR0718I OR0718J OR0718K OR0718L OR0718M OR0718N OR0718O OR0719J OR0719K OR0719L OR0719M OR0719N OR0719O OR0730K OR0730L OR0730M OR0730N OR0730O OR0730P CL0824F-M CL0824G-M CL0824H CL0824I CL0824J CL1133B-M CL1133C-M CL1133D-M CL1133E-M CL1133F CL1133G CL1133H CL1133I CL1134C-M CL1134D CL1134E CL1134F CL1134G CL1134H ET1048 ET1048B ET1048C ET1049C ET1049D ET1049E ET1051B ET1051C ET1051D GS0816B GS0816C GS0817C GS0817D GS0817E GS0830D GS0830F GS0830G GS0988B GS0988C GS0988D GS0988E GS1081 GS1318 GY0827C GY0827D GY0827F GY0827G GY0827H GY1317 HT0815I HT0815J HT0815L HT0815M HT0815N HT0815O LD0832E LD0832G NU0819E NU0819F NU0819G NU0819H NU0826G NU0826H NU0826I NU0826J OR0818C-M OR0818D OR0818E OR0820C OR0820D OR0820E OR0820F OR0820G OR0820I OR0821E OR0822E OR0822F OR0822G OR0822H OR0823E OR0828E OR0828F OR0829B OR0829C OR0968A OR0968B OR1104A OR1104B OR1104C OR1105A OR1105B OR1106 OR1106A OR1106B OR1106C OR1107 OR1107A OR1107B OR1166 CL0927A-M CL0927B CL0927C BS0781A CL0684F GS1323 GS1338 EY0376E CL1158B CV1140 GS1141 OR1271 OR1271A OR1271B OR1271D OR1272 GS1339 GS0997 OR0998 OR0999 CL0280F CL0280G HT1052 HT1052A LD1009B GS1179 GS1179A GS1179B GS1210 GS1210A GS1210B GS1224-TPA GS1270 GS1270A GS1273 OR1226 OR1226A OR1226B OR1235 OR1235A OR1236 OR1236A OR0048L OR0048M OR0048N OR1235A GS1137 GS1001C OR1002B CL1158 CL1158A CL1158C CL1158D CL1158E CL1158F EY0034I EY0034J EY0034L EY0034M EY0034N EY0035I EY0035J EY0035K EY0035L EY0035M EY0035N EY0035O EY0036F EY0036G EY0036H EY0036I EY0036J EY0036K EY0036L EY1221 EY1222 CY1332 ET1110B ET1110C ET1320 ET1320A ET1321 GS1324 GS1325 GS1346 GY1165B GY1326 GY1344 NU1329 OR1319 OR1322 OR1322A OR1327 OR1328 CL1133E-M CV1006D ET1043 OR0431I OR1188B Class II Distribution of a product that did not meet specifications. (labeling error) 802,135 Z-2300-2012