Transseptal Needle with Catheter. RPN recall
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…
Why was Transseptal Needle with Catheter. RPN recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Cook Inc.
- Quantity
- 4789 (OUS only)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)