FDAFDA · Food and drugs·Recall number Z-2300-2012
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.
Published September 5, 2012 · Recall initiated: July 16, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Distribution of a product that did not meet specifications. (labeling error)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SRI Surgical
- Distributor
- Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.
- Lot
- 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 G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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