Cook Inc. Recall 88808
Description: Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Cook Inc. Recall 88808 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0223-2022 |
| Event ID | 88808 |
| Event Description | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 4789 (OUS only) |
| Recall Reason | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. |
| Device Classification | 20211124 |
| Device Code Info | All Lots UDI (01)00827002192614(17)211010(10)9226180 (01)00827002192614(17)211015(10)9234901 (01)00827002192614(17)211015(10)9235946 (01)00827002192614(17)211015(10)9235947 (01)00827002192614(17)211017(10)9242172 (01)00827002192614(17)211120(10)9326411 (01)00827002192614(17)211120(10)9326412 (01)00827002192614(17)211121(10)9328622 (01)00827002192614(17)211130(10)9347132 (01)00827002192614(17)211203(10)9351027 (01)00827002192614(17)211204(10)9354000 (01)00827002192614(17)211210(10)9370544 (01)00827002192614(17)211220(10)9396895 (01)00827002192614(17)220104(10)9419991 (01)00827002192614(17)220109(10)9431068 (01)00827002192614(17)220109(10)9431069 (01)00827002192614(17)220124(10)9472321 (01)00827002192614(17)220128(10)9480776 (01)00827002192614(17)220201(10)9492814 (01)00827002192614(17)220201(10)9492815 (01)00827002192614(17)220201(10)9492816 (01)00827002192614(17)220214(10)9524330 (01)00827002192614(17)220222(10)9545708 (01)00827002192614(17)220222(10)9545720 (01)00827002192614(17)220304(10)9568083 (01)00827002192614(17)220304(10)9568088 (01)00827002192614(17)220311(10)9583267 (01)00827002192614(17)220319(10)9604183 (01)00827002192614(17)220319(10)9604184 (01)00827002192614(17)220322(10)9611406 (01)00827002192614(17)220322(10)9613905 (01)00827002192614(17)220325(10)9617635 (01)00827002192614(17)220328(10)9626175 (01)00827002192614(17)220328(10)9626176 (01)00827002192614(17)220328(10)9626177 (01)00827002192614(17)220402(10)9638768 (01)00827002192614(17)220404(10)9643348 (01)00827002192614(17)220404(10)9643349 (01)00827002192614(17)220409(10)9654385 (01)00827002192614(17)220409(10)9654513 (01)00827002192614(17)220409(10)9654514 (01)00827002192614(17)220409(10)9655757 (01)00827002192614(17)220510(10)9730630 (01)00827002192614(17)220516(10)9743413 (01)00827002192614(17)220516(10)9743414 (01)00827002192614(17)220522(10)9760371 (01)00827002192614(17)220611(10)9802149 (01)00827002192614(17)220620(10)9826728 (01)00827002192614(17)220620(10)9826729 (01)00827002192614(17)220627(10)9840896 (01)00827002192614(17)220628(10)9844564 (01)00827002192614(17)220701(10)9850898 (01)00827002192614(17)220822(10)9966055 (01)00827002192614(17)220826(10)9971573 (01)00827002192614(17)220826(10)9971744 (01)00827002192614(17)220910(10)10002117 (01)00827002192614(17)220917(10)10016709 (01)00827002192614(17)220919(10)10025480 (01)00827002192614(17)220923(10)10031245 (01)00827002192614(17)221023(10)10102218 (01)00827002192614(17)221023(10)10102219 (01)00827002192614(17)221024(10)10105936 (01)00827002192614(17)221024(10)10105937 (01)00827002192614(17)221113(10)10148679 (01)00827002192614(17)221114(10)10151314 (01)00827002192614(17)221118(10)10157368 (01)00827002192614(17)221121(10)10166249 (01)00827002192614(17)221219(10)10224967 (01)00827002192614(17)221219(10)10224968 (01)00827002192614(17)230204(10)10307597 (01)00827002192614(17)230212(10)10324494 (01)00827002192614(17)230220(10)10342526 (01)00827002192614(17)230220(10)10342529 (01)00827002192614(17)230421(10)13145971 (01)00827002192614(17)230421(10)13145972 (01)00827002192614(17)230514(10)13193150 (01)00827002192614(17)230514(10)13193151 (01)00827002192614(17)230609(10)13235106 (01)00827002192614(17)230609(10)13235107 (01)00827002192614(17)230622(10)13260302 (01)00827002192614(17)230714(10)13304618 (01)00827002192614(17)230716(10)13311621 (01)00827002192614(17)230716(10)13311622 (01)00827002192614(17)230716(10)13311623 (01)00827002192614(17)231009(10)13481714 (01)00827002192614(17)231009(10)13481715 (01)00827002192614(17)231112(10)13553814 (01)00827002192614(17)231202(10)13602045 (01)00827002192614(17)231202(10)13602046 (01)00827002192614(17)231202(10)13602047 (01)00827002192614(17)231204(10)13606368 (01)00827002192614(17)231204(10)13606369 (01)00827002192614(17)231204(10)13606370 (01)00827002192614(17)231204(10)13606371 (01)00827002192614(17)240120(10)13702632 (01)00827002192614(17)240120(10)13702633 (01)00827002192614(17)240120(10)13702634 (01)00827002192614(17)240122(10)13707721 (01)00827002192614(17)240311(10)13817370 (01)00827002192614(17)240311(10)13817371 (01)00827002192614(17)240311(10)13817372 (01)00827002192614(17)220222(10)9545708X (01)00827002192614(17)191110(10)NS7433921 (01)00827002192614(17)191201(10)NS7482244 (01)00827002192614(17)191201(10)NS7482246 (01)00827002192614(17)191201(10)NS7482247 (01)00827002192614(17)200712(10)NS8059999 (01)00827002192614(17)211003(10)NS9209497 (01)00827002192614(17)211003(10)NS9209498 (01)00827002192614(17)211003(10)NS9209499 (01)00827002192614(17)211003(10)NS9209500 (01)00827002192614(17)211004(10)NS9212134 |
| Center Classification Date | 20211112 |
| Recall Initiation Date | 20211008 |
| Recalling Firm | Cook Inc. |
| Initial Notification | Letter |
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