Cook Inc. recalls Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. G
Recalled Product
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
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/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
View official government recall
Were you affected by this recall?
If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.
Looking for safe alternatives?
Browse certified-safe products in this category on Amazon →
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime