| Date Initiated by Firm |
January 13, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on August 30, 2010 |
| Recall Number |
Z-0909-04 |
| Recall Event ID |
28840 |
| 510(K)Number |
K032137
|
| Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
| Product |
This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled. |
| Code Information |
DSPROD DSLOT P08030RXB 40903005 P08040RXB 40903348 P08040RXB 40903348 P08040RXB 50104540 P09030RXB X1103044 P09030RXB Y0104852 P09030RXB 41003220 P06040RXB X0903084 P06040RXB X0903084 P07020RXB X0903085 P07030RXB A0104040 P07040RXB X0903087 P07040RXB X0903087 P07040RXB 41003216 P05040RXB X0903081 P06020RXB X0903082 P10020RXB 40903003 P07040RXB X0903087 P08030RXB 40903005 P08040RXB 40104674 P09030RXB Y0104852 P06040RXB X1203033 P07030RXB 51003291 P07030RXB 51003291 P07030RXB A0104040 P07030RXB A0104040 P07030RXB X1003232 P07030RXB X1003232 P07030RXB X1203034 P07030RXB X1203034 P07030RXB X1203034 P07030RXB Y1103310 P07030RXB Y1103310 P07040RXB A0104034 P07040RXB X1203035 P07040RXB X1203035 P08020RXB 40903001 P08030RXB 41003318 P08030RXB 41203043 P08040RXB A1203105 P08040RXB 41003231 P09020RXB 40903002 P09020RXB 41003219 P05020RXB X1103021 P05020RXB X1103021 P05020RXB 41003211 P06020RXB X0903082 P06020RXB X1203031 P07020RXB X0903085 P05040RXB X0903081 P06040RXB X0903084 P05020RXB 41103194 P06040RXB X1203033 P06040RXB X1203033 P07020RXB X0903085 P07040RXB X0903087 P07040RXB 41003216 P06030RXB 51003289 P08030RXB X1003236 P08030RXB X1003236 P08030RXB 41003318 P08030RXB 41203043 P08040RXB Y1103313 P05020RXB 41103194 P05040RXB X0204825 P10020RXB 40903003 P10020RXB 41003221 P08030RXB 41003318 P08040RXB 40903378 P05020RXB X1103021 P05020RXB X1103021 P05030RXB X1103022 P05030RXB 41003212 P05040RXB 40104693 P05040RXB 41003223 P06040RXB X1003229 P06040RXB X1003229 P09030RXB X1003240 P09030RXB X1003240 P09030RXB X1103044 P09030RXB X1203040 P09030RXB Y0104852 P09030RXB 40204813 P09030RXB 41003319 P07040RXB 41003216 P07040RXB 41003216 P08020RXB 41003229 P08030RXB A1103601 P08030RXB A1203147 P08030RXB A1203147 P08030RXB A1203147 P08030RXB X0104899 P08030RXB X0104899 P08030RXB X1003236 P08030RXB X1003236 P08030RXB X1103042 P08030RXB Y0104850 P08030RXB 40104676 P08030RXB 41003230 P08040RXB Y1103313 P08040RXB 41003231 P05020RXB X1103021 P05020RXB 41003211 P05030RXB X1103022 P05030RXB 41003212 P05030RXB 41003212 P05040RXB X0903081 P05040RXB X0903081 P06020RXB A1203094 P06020RXB X0903082 P06020RXB X1003226 P06030RXB 41003225 P06030RXB 51003289 P06030RXB 51003289 P06040RXB X1103024 P07020RXB X0903085 P07020RXB X1003842 P07030RXB X0903086 P07030RXB X0903086 P07030RXB X1203034 P07030RXB 40104679 P06040RXB X1203033 P05040RXB A1203098 P07030RXB 51003291 P08040RXB X1003238 P09030RXB X1103044 P08030RXB 41203043 P08040RXB 40104674 P09030RXB Y0104852 P09030RXB Y0104852 P08030RXB 41003230 P08040RXB 41003231 P06030RXB X1003227 P06030RXB 40104675 P06040RXB X1003229 P07030RXB X0903086 P07040RXB A1103600 P07040RXB 41003216 P08030RXB X1103042 P08030RXB 40903005 P08040RXB 40903378 P10020RXB X1103433 P10020RXB 40903003 P05030RXB 41003212 P05040RXB 41003223 P06030RXB 41003213 P06040RXB X0903084 P06040RXB X1203033 P06040RXB X1203033 P08040RXB X1203038 P09030RXB X1203040 P09030RXB A1203148 P07040RXB 41003216 P05020RXB X1103021 P05040RXB X1103023 P06040RXB 41003226 P09020RXB 40903002 P09030RXB 41003220 P10020RXB 40903003 P08020RXB 40903001 P08030RXB 40903005 P08040RXB Y1103313 P08040RXB Y1103313 P08040RXB 40903348 P06030RXB X0903083 P06030RXB 51003289 P06040RXB X0903084 P08030RXB X1003236 P06040RXB X1203033 P09030RXB X1103044 P09030RXB X1103044 P08030RXB A1103601 P08020RXB X1203036 P08030RXB A1203147 P08030RXB X1003236 P08030RXB 40903005 P08040RXB 40903378 P08040RXB 50104540 P09020RXB X1203039 P09030RXB Y0104852 P06040RXB X1203033 P07020RXB X1003842 P07030RXB A0104040 P07030RXB 51003291 P07030RXB 51003291 P07040RXB X0903087 P06020RXB 41003224 P06030RXB A1203097 P06030RXB 50104537 P06040RXB X1203033 P06040RXB X1203033 P06040RXB X1203033 P07030RXB 40104679 P07040RXB A1103600 P07040RXB X1203035 P08030RXB A1203147 P08030RXB X1003236 P08030RXB X1103042 P08030RXB 41203043 P09030RXB 40204813 P06030RXB 50104537 P08020RXB X1203036 P08040RXB 40903378 P07030RXB A0104040 P07040RXB X0903087 P07040RXB 41003216 P08020RXB 41003229 P08030RXB 40903005 P08030RXB 41003218 P08040RXB X1203038 P05020RXB 41003211 P05030RXB 41003222 P06030RXB A1203097 P06030RXB 50104537 P09030RXB X1003240 P08030RXB 41003318 P05020RXB X1103021 P05020RXB 41103194 P05030RXB A1203096 P05030RXB A1203096 P05040RXB A1203098 P05040RXB A1203098 P07040RXB A1203944 P05040RXB X1103023 P06030RXB X1203032 P07030RXB X1203034 P08030RXB A1203147 P08040RXB X1203038 P05030RXB A1203096 P05040RXB A1203098 P05040RXB A1203098 P06020RXB A1203094 P06020RXB X1203031 P06030RXB X1203032 P06040RXB X1103024 P07020RXB X1103040 P07030RXB X1203034 P07040RXB A1203944 P07030RXB 41003215 P06020RXB 41003224 P07020RXB 41003214 P05040RXB A1203098 P06040RXB X1203033 P08030RXB 40903005 P07040RXB X0903941 P06040RXB A0204768 P07040RXB X0903087 P08030RXB 40104676 P08030RXB 40903005 P08040RXB 50104540 P06030RXB 40104675 P05020RXB X1103021 P05020RXB X1103021 P05020RXB 41103194 P05040RXB X1103023 P05040RXB Y1103302 P05040RXB Y1103302 P06030RXB 51003289 P06040RXB X0903084 P06040RXB X0903084 P08040RXB Y1103313 P07030RXB 51003291 P07040RXB A1103600 P08020RXB X1003234 P05020RXB 41103194 P05030RXB A1203096 P05040RXB X1103023 P06020RXB X0903082 P06030RXB 40104675 P06040RXB 40104677 P07020RXB X1103040 P07030RXB 40104679 P08040RXB 40104674 P07040RXB A1203100 P08020RXB X1203036 P08030RXB 41203043 P07040RXB A0104034 P06040RXB 40104677 P07040RXB X0903941 P07040RXB X1203035 P05030RXB A1203096 P06030RXB 40104675 P06040RXB X1203033 P06040RXB X1203033 P07030RXB X1203034 P06040RXB X0903084 P05040RXB X0903081 P06040RXB X1003229 P07020RXB X1003231 P07020RXB X1003842 P07040RXB X0903941 P08030RXB 40903005 P09020RXB X1003239 P09030RXB X1003240 P06020RXB X1003841 P08030RXB 40903005 P07040RXB X0903941 P07030RXB A0104040 P07040RXB X0903941 P08020RXB 41003217 P08030RXB 40903005 P08040RXB 41003231 P06030RXB 40104675 P10020RXB 41003221 P08030RXB A1203147 P09030RXB X1203040 P07020RXB X1103040 P07040RXB A1203944 P06030RXB X1203032 P06030RXB X1203032 P07020RXB X1103040 P07040RXB A1203944 P08030RXB A1203147 P09030RXB X1203040 P07040RXB X0903087 P08030RXB 40903005 P08030RXB 41003318 P09030RXB X1003240 P05030RXB X1103022 P06020RXB 41003224 P06030RXB A1203097 P06030RXB X1003227 P08030RXB X1103042 P08030RXB 40903005 P08040RXB A1203105 P09020RXB A1203101 P09030RXB A1203148 P10020RXB 41203045 P07020RXB X1103040 P07020RXB 41003214 P07030RXB 51003291 P07040RXB X0903941 P07040RXB X0903941 P08030RXB 40903005 P08030RXB 40903005 P08030RXB 40903005 P09030RXB 41003220 P07040RXB X0903087 P07040RXB X0903941 P08030RXB 40903005 P06040RXB X1103024 P06040RXB X1103024 P07020RXB X1103040 P07020RXB X1103040 P07040RXB A1103600 P07040RXB A1203944 P08020RXB X1203036 P08040RXB X1203038 P08040RXB X1203038 P08040RXB X1203038 P09020RXB X1203039 P07040RXB A1103600 P05030RXB Y1103301 P08030RXB A1203147 P08030RXB 40903005 P08030RXB 40903005 P08030RXB 40903005 P08040RXB X1203038 P09030RXB X1203040 P09030RXB X1203040 P06040RXB X0903084 P07020RXB X0903085 P07020RXB X1003231 P07020RXB X1003231 P07020RXB X1103040 P07030RXB X0903086 P07030RXB X1203034 P07030RXB X1203034 P07030RXB X1203034 P07040RXB X1203035 P07040RXB 41003216 P05020RXB X1003839 P05020RXB X1103021 P05020RXB 41003211 P05030RXB Y1103301 P05030RXB 41003212 P05040RXB Y1103302 P05040RXB 41003223 P06020RXB X0903082 P06020RXB X0903082 P06020RXB X1003841 P06020RXB X1203031 P06030RXB X0903083 P06030RXB 40104675 P08030RXB X1003236 P08030RXB X1103042 P08030RXB X1203037 P08030RXB X1203037 P08030RXB Y0104850 P08030RXB 40104676 P08030RXB X1003236 P08030RXB 41003318 P08030RXB 41003318 P08040RXB 40903378 P07020RXB X1103040 P07030RXB Y1103310 P07030RXB Y1103310 P07040RXB A1203944 P07040RXB X1003233 P05020RXB 41103194 P05040RXB A1203098 P06020RXB X1203031 P06030RXB X0903083 P06030RXB X1203032 P06040RXB X1103024 P06040RXB Y1103303 P05030RXB A1203096 P06030RXB A1203097 P07030RXB X1203034 P08030RXB X1203037 P05030RXB A1203096 P05040RXB 40104693 P07040RXB X1203035 P08040RXB X1003238 P09020RXB A1203101 P09020RXB A1203101 P10020RXB X1103433 P10020RXB 41003221 P10020RXB 41203045 P07020RXB A0104037 P07020RXB X1003842 P07030RXB X0903086 P07030RXB Y0104839 P07040RXB A0104034 P07040RXB 41003216 P08020RXB 41003229 P08030RXB 41003318 P08030RXB 41203043 P06020RXB A1203094 P06020RXB 41003224 P06030RXB X1203032 P06030RXB 40104675 P06030RXB 41003213 P06030RXB 50104537 P06040RXB A0204768 P06040RXB X1103024 P06040RXB Y1103303 P07030RXB X1003232 P05030RXB Y1103301 P05040RXB A1203098 P06030RXB 51003289 P06040RXB 40104677 P07030RXB X1003232 P08030RXB 41003230 P05030RXB Y1103301 P06030RXB X1003227 P07020RXB X1003231 P07020RXB X1003842 P05020RXB 41003211 P06020RXB X1003226 P06020RXB 41003224 P07040RXB A0104034 P07040RXB X0903087 P08020RXB 41003229 P08030RXB A1103601 P08030RXB 41003318 P08040RXB X1203038 P08040RXB 40903378 P10020RXB 41003221 P07030RXB 41003228 P07040RXB 41003216 P05030RXB Y1103301 P07030RXB X0903086 P07030RXB Y1103310 P07030RXB 51003291 P07040RXB 41003216 P08040RXB A1203105 P09030RXB A1203148 P09030RXB Y0204761 P10020RXB X1103433 P05020RXB 41003211 P05030RXB X1203030 P05030RXB 41003212 P05040RXB A1203098 P05040RXB X0903081 P06020RXB A1203094 P06020RXB X1003226 P06020RXB X1003226 P06020RXB X1203031 P06030RXB A1203097 P06030RXB X0903083 P06030RXB X1203032 P06040RXB X0903084 P06040RXB Y1103303 P07020RXB X0903085 P07020RXB X1003231 P07020RXB X1003842 P08030RXB 40903005 P07030RXB X1203034 P07040RXB X1203035 P08040RXB X1203038 P09020RXB X1203039 P09030RXB 40104681 P07020RXB X1103040 P07020RXB X1103040 P07020RXB 41003214 P05020RXB X0903079 P05030RXB 41003212 P05040RXB X0903081 P05040RXB Y1103302 P06030RXB X0903083 P06030RXB 50104537 P07030RXB X0903086 P08040RXB 40104674 P06020RXB X0903082 P06030RXB X0903083 P07020RXB X0903085 P07030RXB X0903086 P05020RXB X1103021 P06040RXB X1203033 P06040RXB Y1103303 P05030RXB X1203030 P06020RXB A1203094 P06030RXB 50104537 P07020RXB A0204771 P07030RXB Y0104839 P08020RXB 40104678 P08030RXB X0104899 P08040RXB 41003231 P07030RXB 51003291 P07040RXB X1003233 P08030RXB 41003230 P08030RXB Y0104850 P07030RXB X1203034 P08040RXB 40104674 P09030RXB 40104681 P07040RXB A1203944 P08040RXB A1203105 P06030RXB A1203097 P07030RXB X1203034 P07030RXB X1203034 P08030RXB 41203043 P06020RXB A1203094 P06020RXB A1203094 P06020RXB X1203031 P06020RXB 41003224 P07020RXB X1003842 P07020RXB X1103040 P07020RXB 41003214 P07030RXB X1203034 P05020RXB X1103021 P06020RXB X1003226 P07030RXB Y1103310 P07040RXB A1103600 P08030RXB X1103042 P08040RXB Y1103313 P09030RXB X1103044 P05020RXB X1003839 P05030RXB Y1103301 P06020RXB X1003841 P06030RXB 51003289 P06040RXB X1003229 P07020RXB X1003231 P07020RXB X1103040 P07020RXB X1103040 P07030RXB 51003291 P07040RXB X1003233 P08020RXB 41003217 P09030RXB 40204813 P08030RXB X1103042 P07040RXB A1103600 P08020RXB X1103431 P08020RXB X1103431 P08020RXB X1203036 P08040RXB X1203038 P08040RXB Y1103313 P08040RXB Y1103313 P08040RXB 50104540 P10020RXB X1103433 P06020RXB A1203094 P07020RXB X1003842 P09030RXB X1203040 P09030RXB Y0204761 P07040RXB X0903087 P07040RXB X0903941 P08040RXB A1203105 P08030RXB A1203147 P08030RXB 41203043 P08040RXB X1203038 P09030RXB X1203040 P09030RXB 40104681 P07030RXB X1203034 P07040RXB A1203944 P08030RXB X1203037 P08030RXB 41203043 P08040RXB X1203038 P09020RXB A1203101 P09020RXB X1203039 P10020RXB X1103433 P07030RXB X1203034 P07040RXB A1103600 P07040RXB A1203100 P08020RXB X1203036 P07030RXB X1203034 P09030RXB A1203148 P07030RXB X1203034 P08030RXB X1203037 P08030RXB 41003218 P09030RXB Y0204761 P09030RXB 41003220 P05020RXB X1103021 P05030RXB A1203096 P06020RXB X1203031 P06030RXB A1203097 P07020RXB X1103040 P07030RXB X1203034 P08020RXB X1203036 P08030RXB X1203037 P09020RXB A1203101 P09030RXB X1203040 P08030RXB 41203043 P07030RXB X1203034 P07040RXB A1103600 P08030RXB X1203037 P09030RXB X1203040 P05040RXB X1103023 P05030RXB 41003222 P05040RXB 41003223 P06030RXB 41003213 P06040RXB 41003226 P07030RXB X1203034 P08030RXB X1203037 P08040RXB X1203038 P09030RXB X1203040 P05020RXB X1003839 P06030RXB X1203032 P08020RXB X1103431 P08030RXB X1103042 P09020RXB A1203101 P06020RXB X0903082 P06020RXB X1003841 P08020RXB X1203036 P08030RXB 41203043 P08030RXB A1203147 P08040RXB X1203038 P09030RXB X1203040 P07030RXB Y1103310 P08040RXB A1203105 P09030RXB A1203148 P07040RXB A1203100 P08030RXB X1103042 P07030RXB Y1103310 P08030RXB 41003318 P06020RXB 41003224 P06030RXB 41003225 P07020RXB 41003214 P07030RXB 41003228 P07020RXB X1003842 P07040RXB A1103600 P08020RXB X1103431 P08040RXB 50104540 P09030RXB X1203040 P07040RXB X1203035 P08030RXB X1103042 P08040RXB X1003238 P06040RXB Y1103303 P09030RXB X1103044 P07030RXB Y1103310 P09030RXB A1203148 P05020RXB X1103021 P05030RXB X1103022 P05040RXB X1103023 P06020RXB A1203094 P07020RXB X1003842 P07030RXB Y1103310 P08020RXB X1103431 P08040RXB A1203105 P08040RXB 41203044 P05020RXB X1103021 P05040RXB X1103023 P05020RXB X1003839 P05040RXB X0903081 P05040RXB 40104693 P06020RXB X0903082 P08030RXB 40903005 P08040RXB 40903378 P06040RXB A0204768 P06040RXB X0903084 P07040RXB A0104034 P07040RXB X0903087 P05030RXB X1103022 P05040RXB X1103023 P08030RXB 40104676 P08030RXB 40903005 P08030RXB 40903005 P09030RXB X1003240 P06040RXB X1003229 P07020RXB 41003227 P07040RXB A1203100 P07040RXB X0903941 P07040RXB X0903941 P07020RXB X0903085 P07020RXB 41003227 P07030RXB X0903086 P07030RXB X1203034 P08020RXB 40903001 P07020RXB X1103040 P09030RXB 40104681 P05040RXB X1103023 P07040RXB A1203944 P08030RXB X1103042 P05030RXB Y1103301 P05040RXB Y1103302 P07040RXB A1203944 P08040RXB X1203038 P08030RXB 40903005 P08030RXB 41203043 P08030RXB 41203043 P07020RXB X1003842 P07030RXB X0903086 P07030RXB X1003232 P07030RXB Y1103310 P07040RXB X0903087 P07040RXB X0903087 P07040RXB X0903087 P08020RXB X1103431 P05020RXB X1103021 P05030RXB X1103022 P06020RXB A1203094 P08030RXB 40104676 P08040RXB 50104540 P08040RXB 50104540 P09030RXB Y0104852 P07040RXB X0903087 P06040RXB X1003229 P07020RXB X1103040 P07020RXB X1103040 P07020RXB 41003227 P07030RXB X0903086 P07030RXB X0903086 P07030RXB X0903086 P07030RXB X1003232 P07030RXB Y0104839 P07030RXB Y1103310 P07030RXB Y1103310 P07030RXB 51003291 P07040RXB A1103600 P07040RXB X0903087 P07040RXB X1003233 P08020RXB X1203036 P08020RXB 41003217 P08030RXB Y0104850 P08030RXB 40903005 P08030RXB 40903005 P08040RXB 40903348 P09020RXB A1203101 P09030RXB X1103044 P05030RXB Y1103301 P06020RXB A1203094 P06030RXB X1003227 P08030RXB 41003230 P08030RXB 41203043 P08040RXB 40903348 P09030RXB 41003220 P07030RXB X0903086 P07040RXB A0104034 P07040RXB A1203944 P08030RXB 40903005 P05030RXB X0903080 P05040RXB 40104693 P06030RXB X0903083 P06030RXB X1203032 P06030RXB X1203032 P06030RXB 50104537 P06030RXB 50104537 P06040RXB X1103024 P05030RXB A1203096 P06040RXB X1203033 P07030RXB X1003232 P07040RXB X0903087 P07040RXB X1203035 P08030RXB 41003230 P09030RXB X1003240 P06040RXB X0903084 P06030RXB X1003227 P06040RXB X0903084 P06040RXB X1003229 P08030RXB A1203147 P08040RXB X1203038 P08030RXB A1103601 P08030RXB A1103601 P08030RXB X1103042 P08030RXB 40903005 P07040RXB X0903087 P08030RXB 40903005 P09030RXB X1103044 P07040RXB A1103600 P07040RXB A1103600 P08020RXB X1003234 P08020RXB X1103431 P08030RXB A1103601 P08040RXB 41203044 P08040RXB 41203044 P05030RXB X1103022 P05040RXB X1103023 P06030RXB A1203097 P06040RXB Y1103303 P08030RXB X1103042 P08030RXB X1103042 P07030RXB Y1103310 P07040RXB A0104034 P05020RXB X1003839 P05030RXB X1103022 P05040RXB A1203098 P05040RXB Y1103302 P08020RXB 40903001 P08030RXB X1003236 P08030RXB 40903005 P08030RXB 40903005 P08030RXB 41003230 P08040RXB X1003238 P08040RXB X1203038 P09030RXB X1203040 P09030RXB Y0104852 P07020RXB X0903085 P07030RXB 51003291 P07040RXB X0903941 P07040RXB 41003216 P08020RXB 40903001 P09030RXB 41003220 P08030RXB 40903005 P08030RXB 40903005 P07030RXB X0903086 P07040RXB X0903087 P07040RXB X0903087 P07020RXB X0903085 P07030RXB X0903086 P07030RXB 51003291 P07040RXB X0903087 P07040RXB X1003233 P08020RXB 40903001 P08020RXB 40903001 P08030RXB 40903005 P08030RXB 40903005 P08040RXB 40903378 P05030RXB X1103022 P05040RXB Y1103302 P06020RXB X0903082 P06020RXB X1003226 P05020RXB 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P07020RXB X1003842 P07030RXB 51003291 P07040RXB A0104034 P07040RXB X0903087 P07040RXB X0903087 P07040RXB X0903087 P08030RXB 40903005 P06040RXB X0903084 P07040RXB X0903941 P08030RXB X1103042 P08030RXB 40903005 P08030RXB 41003318 P08030RXB 40903005 P07040RXB X0903941 P07040RXB A1103600 P05040RXB X0903081 P05040RXB X0903081 P05040RXB Y1103302 P06040RXB A0204768 P06040RXB X0903084 P06040RXB X1003229 P07030RXB Y0104839 P07040RXB X0903941 P08040RXB 40903378 P08030RXB A1103601 P08030RXB 40104676 P08030RXB 41003318 P08040RXB A1203105 P08040RXB 40903348 P08040RXB 41003231 P09020RXB 41003219 P09030RXB X1003240 P09030RXB Y0204761 P10020RXB 41003221 P08030RXB A1203147 P08030RXB X0104899 P09030RXB X1203040 P09030RXB 41003319 P05040RXB A1203098 P09030RXB X1103044 P10020RXB 40903003 P07030RXB 51003291 P08040RXB 40903348 P08040RXB Y1103313 P05040RXB X0903081 P05040RXB 41003223 P06040RXB A0204768 P06040RXB 41003226 P08040RXB X0104903 P08020RXB 40903001 P08030RXB 40903005 P07040RXB A0104034 P06040RXB A0204768 P08030RXB X1003236 P08040RXB X1003238 P09030RXB X1003240 P08030RXB X1003236 P08020RXB 40903001 P08030RXB 40903005 P08030RXB 41003218 P09030RXB 40104681 P09030RXB 41003319 P10020RXB 40903003 P05040RXB 41003223 P06040RXB 41003226 P07040RXB A1203944 P06040RXB 40104677 P08030RXB X1103042 P09030RXB X1103044 P10020RXB 41003221 P05020RXB X0903079 P05020RXB X1103021 P05030RXB 41003212 P05040RXB X0903081 P06020RXB X0903082 P06030RXB X0903083 P06030RXB X0903083 P06040RXB X0903084 P06040RXB X0903084 P07020RXB X0903085 P07030RXB X0903086 P07030RXB X0903086 P07040RXB X0903087 P07040RXB X0903087 P07040RXB X0903941 P08030RXB 40903005 P08030RXB 40903005 P08040RXB 40903348 P08030RXB X1203037 P08030RXB 40104676 P08030RXB 40903005 P08040RXB X1203038 P09030RXB X1203040 P06040RXB X1103024 P06040RXB 40104677 P07030RXB X1203034 P07040RXB A1203944 P07040RXB X0903941 P05030RXB A1203096 P05040RXB A1203098 P06030RXB X1203032 P06030RXB 40104675 P08030RXB 40104676 P08030RXB 40903005 P08040RXB 50104540 P09030RXB Y0104852 P07030RXB 40104679 P07040RXB X0903087 P08030RXB 40903005 P08030RXB 41203043 P08040RXB 40104674 P09030RXB 40104681 P06040RXB X1203033 P07030RXB A0104040 P07040RXB X0903941 P07040RXB X1203035 P06030RXB 40104675 P08030RXB 40104676 P08020RXB 41003217 P07030RXB 41003228 P05030RXB 41003222 P05040RXB 41003223 P06040RXB 41003226 P07020RXB 41003214 P06030RXB X1203032 P06040RXB X1103024 P08030RXB X1203037 P05020RXB X0903079 P07040RXB A1103600 P07040RXB A1103600 P08040RXB X1003238 P08040RXB X1203038 P07020RXB X0903085 P07020RXB 41003214 P05030RXB 41003222 P05040RXB 41003223 P06020RXB A1203094 P06030RXB 50104537 P06040RXB A0204768 P07020RXB A0204771 P07030RXB Y0104839 P07040RXB A0104034 P08020RXB 40104678 P08030RXB X0104899 P08040RXB X0104903 P09020RXB A1203101 P09030RXB 40204813 P08030RXB 41203043 P08040RXB 40104674 P09030RXB 40104681 P10020RXB 41203045 P08030RXB 41003318 P09030RXB X1003240 P05020RXB 41003211 P06020RXB 41003224 P06030RXB 41003213 P07030RXB 41003215 P07040RXB 41003216 P07030RXB 51003291 P08030RXB X1003236 P08030RXB X1103042 P10020RXB X1103433 P05020RXB X1003839 P05030RXB X1103022 P06020RXB A1203094 P06030RXB A1203097 P06040RXB X1003229 P08030RXB 40903005 P08030RXB 41203043 P08040RXB 40104674 P09030RXB 40104681 P07040RXB X0903087 P07040RXB X1203035 P06040RXB X1103024 P07020RXB X1003842 P07020RXB X1103040 P07020RXB 41003214 P07030RXB 41003228 P07040RXB X0903941 P08020RXB 41003229 P08030RXB 40903005 P05020RXB X1003839 P05030RXB X1103022 P05030RXB Y1103301 P05040RXB X1103023 P06020RXB A1203094 P06020RXB 41003224 P06030RXB A1203097 P06030RXB 41003225 P08030RXB 40903005 P08040RXB X1003238 P07020RXB X1103040 P07030RXB A0104040 P07030RXB 51003291 P08040RXB X1203038 P09030RXB X1003240 P09030RXB X1103044 P09030RXB X1103044 P07020RXB X0903085 P07030RXB X0903086 P08030RXB A1103601 P08030RXB 40903005 P08030RXB A1203147 P08030RXB A1203147 P06020RXB 41003224 P06030RXB 51003289 P06040RXB X1103024 P07020RXB X1103040 P08040RXB X1203038 P07030RXB X1203034 P07040RXB X0903941 P08020RXB X1103431 P08030RXB X1003236 P08030RXB Y0104850 P08030RXB 41003318 P06030RXB X1203032 P07030RXB X0903086 P07040RXB A0104034 P07040RXB A0104034 P08040RXB X1203038 P09030RXB Y0104852 P06030RXB X0903083 P05020RXB X1003839 P05030RXB 41003212 P05040RXB X1103023 P06020RXB 41003224 P06040RXB X1103024 P06040RXB Y1103303 P07020RXB X1003842 P07020RXB 41003214 P07030RXB 41003228 P07040RXB X0903941 P08020RXB X1103431 P08020RXB 41003217 P08020RXB 41003229 P08030RXB 40903005 P08030RXB X1203037 P08030RXB 40903005 P08040RXB X1203038 P08040RXB Y1103313 P08040RXB 40104674 P08040RXB 40903348 P06030RXB X0903083 P08020RXB X1203036 P08030RXB X1203037 P07020RXB X1103040 P07040RXB A1203944 P08020RXB X1103431 P08030RXB A1203147 P09020RXB A1203101 P07030RXB 51003291 P08040RXB 40903348 P09030RXB 41003319 P07030RXB X1203034 P07040RXB A1203944 P06030RXB X1203032 P06040RXB X1103024 P07040RXB X0903087 P08030RXB X1103042 P08040RXB A1203105 P09030RXB 41003319 P06040RXB X0903084 P06020RXB A1203094 P06030RXB A1203097 P07030RXB X1203034 P08030RXB X1003236 P08030RXB X1003236 P08030RXB A1203147 P08040RXB X1203038 P08020RXB X1103431 P06040RXB X0903084 P07020RXB X0903085 P07030RXB X0903086 P07030RXB X1203034 P07030RXB 51003291 P07040RXB X0903087 P07040RXB X1003233 P07040RXB 41003216 P08020RXB 40903001 P08030RXB 40903005 P08030RXB 41003230 P08040RXB X1003238 P08040RXB 40903348 P06020RXB X0903082 P06030RXB X0903083 P06030RXB X0903083 P07040RXB X0903087 P07040RXB X1003233 P07040RXB 41003216 P07040RXB 41003216 P08030RXB 41003230 P08030RXB 41003230 P08030RXB 41003230 P08040RXB X1003238 P08040RXB 40903348 P07030RXB X1203034 P07030RXB 51003291 P07030RXB X0903086 P0640RXCE Y0204753 P0930RXCE Y0204762 P0630RXCE Y0204752 P0820RXCE A0204776 P0830RXCE A0204777 P0840RXCE A0204780 P0730RXCE A0204772 P0830RXCE X0204828 P0720RXCE X0204822 P0740RXCE 40204801 P0840RXCE Y0204758 P0730RXCE X0204824 P06040RXB X0903084 P07020RXB 41003214 P07020RXB 41003227 P08040RXB X1203038 P08040RXB X1203038 P08040RXB Y1103313 P09020RXB 40903002 P05020RXB X1103021 P05030RXB A1203096 P07020RXB X0903085 P07030RXB X1203034 P07030RXB 51003291 P08020RXB 40903001 P08030RXB A1103601 P08030RXB X1203037 P09030RXB X1203040 P06020RXB X0903082 P08030RXB A1103601 P05040RXB A1203098 P06030RXB X0903083 P08030RXB 40903005 P08030RXB 41003230 P08040RXB 40903348 P07040RXB X1003233 P07040RXB X0903087 P07030RXB X0903086 P09030RXB 41003319 P0620RXCE Y0204751 P0730RXCE A0204772 P0630RXCE Y0204752 P0920RXCE A0204784 P0530RXCE Y0204749 P0520RXCE Y0204748 P0540RXCE Y0204750 P0640RXCE Y0204753 P0820RXCE A0204776 P0830RXCE A0204777 P0840RXCE A0204780 P0930RXCE Y0204762 P0630RXCE A0204770 P0730RXCE Y0204755 P0840RXCE X1103595 P0830RXCE X1103597 P0930RXCE X1103596 P0730RXCE X1103593 P05020RXB X1103021 P05020RXB X1103021 P05030RXB A1203096 P05040RXB A1203098 P06020RXB A1203094 P06030RXB A1203097 P06030RXB X1203032 P06040RXB X1003229 P06040RXB X1203033 P07020RXB A0204771 P07020RXB X1003231 P07020RXB X1003842 P07030RXB 40104679 P08030RXB A1203147 P08030RXB X1003236 P08040RXB A0204782 P08040RXB A1203105 P08040RXB X1203038 P09030RXB X1203040 P09030RXB Y0204761 P05020RXB X1003839 P08020RXB X1003234 P08030RXB 40104676 P08030RXB 41003230 P08040RXB A0204782 P0820RXCE X0104895 P09030RXB X1003240 P05030RXB X1103022 P07020RXB X1103040 P07040RXB A0104034 P0620RXCE X0204821 P08040RXB 50104540 P0620RXCE X0204821 P0820RXCE X0104895 P08040RXB 50104540 P07030RXB 51003291 P0520RXCE 50104534 P0620RXCE Y0104835 P0540RXCE 50104536 P0530RXCE 50104535 P0640RXCE X0104958 P1020RXCE 50104544 P0920RXCE 50104541 P0630RXCE Y0104844 P0640RXCE Y0104837 P0740RXCE A0204774 P0630RXCE X0104957 P1020RXCE A0204785 P0920RXCE X0204831 P0740RXCE Y0104846 P0840RXCE Y0104848 P0620RXCE X0204821 P0920RXCE X0204831 P0720RXCE Y0104849 P0540RXCE X0204826 P0620RXCE X0104896 P0820RXCE X0104895 P0830RXCE Y0104847 P0930RXCE 50104542 P0740RXCE X0104901 P0830RXCE X0104898 P0730RXCE X0104897 P0820RXCE Y0204756 P0720RXCE X0104894 P0830RXCE Y0204757 P0630RXCE X0204823 P08030RXB 40903005 P08040RXB 40903378 P08040RXB Y1103313 P08040RXB 40104674 |
Recalling Firm/
Manufacturer |
Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
|
| For Additional Information Contact |
Hal Delgado
786-313-2108
|
Manufacturer Reason
for Recall |
Air may be introduced into this Stent system when used with certain size acessory devices.
|
FDA Determined
Cause 2 |
Other |
| Action |
On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling. |
| Quantity in Commerce |
7815 |
| Distribution |
Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = FGE and Original Applicant = CORDIS CORP.
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