| | Class 1 Device Recall Cook Beacon Tip 5.0 Fr Angiographic Catheter |  |
| Date Initiated by Firm | May 15, 2025 |
|---|
| Date Posted | June 16, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1902-2025 |
|---|
| Recall Event ID |
96848 |
| 510(K)Number | K173289 |
|---|
| Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
|
| Product | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration). |
|---|
| Code Information |
1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087962(17)260202(30)5(10)15881668 (box), Lot Number 15881668;
1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260219(10)15903001 (product), (01)10827002087962(17)260219(30)5(10)15903001 (box), Lot Number 15903001;
1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260306(10)NS15932463 (product), (01)10827002087962(17)260306(30)5(10)NS15932463 (box), Lot Number NS15932463;
2) HNBR5.0-35-100-P-NS-DAV (RPN) G08699 (GPN), UDI: (01)00827002086999(17)260411(10)16003554 (product), (01)10827002086996(17)260411(30)5(10)16003554 (box), Lot Number 16003554;
3) HNBR5.0-35-100-P-NS-H1 (RPN) G08421 (GPN), UDI: (01)00827002084216(17)260314(10)15948423 (product), (01)10827002084213(17)260314(30)5(10)15948423 (box), Lot Number 15948423;
4) HNBR5.0-35-100-P-NS-JB2 (RPN) G08809 (GPN), UDI: (01)00827002088092(17)260319(10)15953578 (product), (01)10827002088099(17)260319(30)5(10)15953578 (box), Lot Number 15953578;
5) HNBR5.0-35-100-P-NS-SIM1 (RPN) G08471 (GPN), UDI: (01)00827002084711(17)260401(10)15984088 (product), (01)10827002084718(17)260401(30)5(10)15984088 (box), Lot Number 15984088;
6) HNBR5.0-35-100-P-NS-SIM2 (RPN) G08422 (GPN), UDI: (01)00827002084223(17)260220(10)15907359 (product), (01)10827002084220(17)260220(30)5(10)15907359 (box), Lot Number 15907359;
7) HNBR5.0-35-100-P-NS-SIM3 (RPN) G08597 (GPN), UDI: (01)00827002085978(17)260201(10)15879285 (product), (01)10827002085975(17)260201(30)5(10)15879285 (box), Lot Number 15879285;
8) HNBR5.0-35-100-P-NS-VERT (RPN) G11483 (GPN), UDI: (01)00827002114838(17)260222(10)NS15912380 (product), (01)10827002114835(17)260222(30)5(10)NS15912380 (box), Lot Number NS15912380;
9) HNBR5.0-35-125-P-NS-C2 (RPN) G12899 (GPN), UDI: (01)00827002128996(17)260407(10)NS15995667 (product), (01)10827002128993(17)260407(30)5(10)NS15995667 (box), Lot Number NS15995667;
10) HNBR5.0-35-125-P-NS-VANSCHIE1 (RPN) G35733 (GPN), UDI: (01)00827002357334(17)260325(10)15972583 (product), (01)10827002357331(17)260325(30)5(10)15972583 (box), Lot Number 15972583;
11) HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260308(10)15937655 (product), (01)10827002357362(17)260308(30)5(10)15937655 (box), Lot Number 15937655;
11) HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260325(10)15972584 (product), (01)10827002357362(17)260325(30)5(10)15972584 (box), Lot Number 15972584;
11) HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260408(10)15995781 (product), (01)10827002357362(17)260408(30)5(10)15995781 (box), Lot Number 15995781;
12) HNBR5.0-35-125-P-NS-VANSCHIE5 (RPN) G35737 (GPN), UDI: (01)00827002357372(17)260408(10)15995782 (product), (01)10827002357379(17)260408(30)5(10)15995782 (box), Lot Number 15995782;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260202(10)15881670 (product), (01)10827002097510(17)260202(30)5(10)15881670 (box), Lot Number 15881670;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260213(10)15895236 (product), (01)10827002097510(17)260213(30)5(10)15895236 (box), Lot Number 15895236;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260314(10)15948424 (product), (01)10827002097510(17)260314(30)5(10)15948424 (box), Lot Number 15948424;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260320(10)15957900 (product), (01)10827002097510(17)260320(30)5(10)15957900 (box), Lot Number 15957900;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260326(10)15976870 (product), (01)10827002097510(17)260326(30)5(10)15976870 (box), Lot Number 15976870;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260327(10)15979535 (product), (01)10827002097510(17)260327(30)5(10)15979535 (box), Lot Number 15979535;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260328(10)15980166 (product), (01)10827002097510(17)260328(30)5(10)15980166 (box), Lot Number 15980166;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260405(10)15993143 (product), (01)10827002097510(17)260405(30)5(10)15993143 (box), Lot Number 15993143;
13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260415(10)16008638 (product), (01)10827002097510(17)260415(30)5(10)16008638 (box), Lot Number 16008638;
14) HNBR5.0-35-40-P-NS-VANSCHIE3 (RPN) G31408 (GPN), UDI: (01)00827002314085(17)260318(10)15950809 (product), (01)10827002314082(17)260318(30)5(10)15950809 (box), Lot Number 15950809;
15) HNBR5.0-35-65-P-NS-C1 (RPN) G08441 (GPN), UDI: (01)00827002084414(17)260325(10)15972586 (product), (01)10827002084411(17)260325(30)5(10)15972586 (box), Lot Number 15972586;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260213(10)15895237 (product), (01)10827002084428(17)260213(30)5(10)15895237 (box), Lot Number 15895237;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260222(10)15912387 (product), (01)10827002084428(17)260222(30)5(10)15912387 (box), Lot Number 15912387;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260325(10)15972587 (product), (01)10827002084428(17)260325(30)5(10)15972587 (box), Lot Number 15972587;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260326(10)15976871 (product), (01)10827002084428(17)260326(30)5(10)15976871 (box), Lot Number 15976871;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260327(10)15979536 (product), (01)10827002084428(17)260327(30)5(10)15979536 (box), Lot Number 15979536;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260328(10)15980167 (product), (01)10827002084428(17)260328(30)5(10)15980167 (box), Lot Number 15980167;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260405(10)15993144 (product), (01)10827002084428(17)260405(30)5(10)15993144 (box), Lot Number 15993144;
16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260411(10)16003545 (product), (01)10827002084428(17)260411(30)5(10)16003545 (box), Lot Number 16003545;
17) HNBR5.0-35-65-P-NS-C3 (RPN) G08443 (GPN), UDI: (01)00827002084438(17)260327(10)15978551 (product), (01)10827002084435(17)260327(30)5(10)15978551 (box), Lot Number 15978551;
18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260311(10)15940019 (product), (01)10827002114583(17)260311(30)5(10)15940019 (box), Lot Number 15940019;
18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260320(10)15957901 (product), (01)10827002114583(17)260320(30)5(10)15957901 (box), Lot Number 15957901;
18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260405(10)15993139 (product), (01)10827002114583(17)260405(30)5(10)15993139 (box), Lot Number 15993139;
18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260411(10)16003556 (product), (01)10827002114583(17)260411(30)5(10)16003556 (box), Lot Number 16003556;
19) HNBR5.0-35-65-P-NS-RBT (RPN) G57015 (GPN), UDI: (01)00827002570153(17)260228(10)15921475 (product), (01)10827002570150(17)260228(30)5(10)15921475 (box), Lot Number 15921475;
19) HNBR5.0-35-65-P-NS-RBT (RPN) G57015 (GPN), UDI: (01)00827002570153(17)260312(10)15942327 (product), (01)10827002570150(17)260312(30)5(10)15942327 (box), Lot Number 15942327;
20) HNBR5.0-35-65-P-NS-RC1 (RPN) G08469 (GPN), UDI: (01)00827002084698(17)260325(10)15972578 (product), (01)10827002084695(17)260325(30)5(10)15972578 (box), Lot Number 15972578;
21) HNBR5.0-35-65-P-NS-RC2 (RPN) G08470 (GPN), UDI: (01)00827002084704(17)260325(10)15972577 (product), (01)10827002084701(17)260325(30)5(10)15972577 (box), Lot Number 15972577;
22) HNBR5.0-35-65-P-NS-RDC (RPN) G08596 (GPN), UDI: (01)00827002085961(17)260419(10)16017882 (product), (01)10827002085968(17)260419(30)5(10)16017882 (box), Lot Number 16017882;
23) HNBR5.0-35-65-P-NS-RIM (RPN) G08444 (GPN), UDI: (01)00827002084445(17)260412(10)16005235 (product), (01)10827002084442(17)260412(30)5(10)16005235 (box), Lot Number 16005235;
24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260306(10)15932470 (product), (01)10827002137957(17)260306(30)5(10)15932470 (box), Lot Number 15932470;
24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260306(10)15932471 (product), (01)10827002137957(17)260306(30)5(10)15932471 (box), Lot Number 15932471;
24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260401(10)15984090 (product), (01)10827002137957(17)260401(30)5(10)15984090 (box), Lot Number 15984090;
25) HNBR5.0-35-65-P-NS-VANSCHIE2 (RPN) G13794 (GPN), UDI: (01)00827002137943(17)260405(10)15993140 (product), (01)10827002137940(17)260405(30)5(10)15993140 (box), Lot Number 15993140;
26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260315(10)15948952 (product), (01)10827002137926(17)260315(30)5(10)15948952 (box), Lot Number 15948952;
26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260319(10)15953576 (product), (01)10827002137926(17)260319(30)5(10)15953576 (box), Lot Number 15953576;
26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260320(10)15957904 (product), (01)10827002137926(17)260320(30)5(10)15957904 (box), Lot Number 15957904;
26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260408(10)15995865 (product), (01)10827002137926(17)260408(30)5(10)15995865 (box), Lot Number 15995865;
27) HNBR5.0-35-65-P-NS-VANSCHIE4 (RPN) G13783 (GPN), UDI: (01)00827002137837(17)260205(10)15882844 (product), (01)10827002137834(17)260205(30)5(10)15882844 (box), Lot Number 15882844;
27) HNBR5.0-35-65-P-NS-VANSCHIE4 (RPN) G13783 (GPN), UDI: (01)00827002137837(17)260320(10)15957905 (product), (01)10827002137834(17)260320(30)5(10)15957905 (box), Lot Number 15957905;
28) HNBR5.0-35-65-P-NS-VANSCHIE5 (RPN) G13793 (GPN), UDI: (01)00827002137936(17)260216(10)15901238 (product), (01)10827002137933(17)260216(30)5(10)15901238 (box), Lot Number 15901238;
28) HNBR5.0-35-65-P-NS-VANSCHIE5 (RPN) G13793 (GPN), UDI: (01)00827002137936(17)260320(10)15957910 (product), (01)10827002137933(17)260320(30)5(10)15957910 (box), Lot Number 15957910;
29) HNBR5.0-35-80-P-NS-C2 (RPN) G11202 (GPN), UDI: (01)00827002112025(17)260315(10)15948953 (product), (01)10827002112022(17)260315(30)5(10)15948953 (box), Lot Number 15948953;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260228(10)15921476 (product), (01)10827002570174(17)260228(30)5(10)15921476 (box), Lot Number 15921476;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260228(10)15924172 (product), (01)10827002570174(17)260228(30)5(10)15924172 (box), Lot Number 15924172;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260319(10)15956478 (product), (01)10827002570174(17)260319(30)5(10)15956478 (box), Lot Number 15956478;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260322(10)15971078 (product), (01)10827002570174(17)260322(30)5(10)15971078 (box), Lot Number 15971078;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260328(10)15981406 (product), (01)10827002570174(17)260328(30)5(10)15981406 (box), Lot Number 15981406;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260328(10)15981407 (product), (01)10827002570174(17)260328(30)5(10)15981407 (box), Lot Number 15981407;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260403(10)15988580 (product), (01)10827002570174(17)260403(30)5(10)15988580 (box), Lot Number 15988580;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260403(10)15988581 (product), (01)10827002570174(17)260403(30)5(10)15988581 (box), Lot Number 15988581;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260408(10)15995788 (product), (01)10827002570174(17)260408(30)5(10)15995788 (box), Lot Number 15995788;
30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260315(10)NS15948960 (product), (01)10827002570174(17)260315(30)5(10)NS15948960 (box), Lot Number NS15948960;
31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260315(10)15948954 (product), (01)10827002085814(17)260315(30)5(10)15948954 (box), Lot Number 15948954;
31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260403(10)15988266 (product), (01)10827002085814(17)260403(30)5(10)15988266 (box), Lot Number 15988266;
31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260311(10)NS15940014 (product), (01)10827002085814(17)260311(30)5(10)NS15940014 (box), Lot Number NS15940014;
32) HNBR5.0-38-100-P-NS-H1 (RPN) G08419 (GPN), UDI: (01)00827002084193(17)260201(10)15879274 (product), (01)10827002084190(17)260201(30)5(10)15879274 (box), Lot Number 15879274;
33) HNBR5.0-38-100-P-NS-JB1 (RPN) G08583 (GPN), UDI: (01)00827002085831(17)260318(10)15950803 (product), (01)10827002085838(17)260318(30)5(10)15950803 (box), Lot Number 15950803;
34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260326(10)15975568 (product), (01)10827002114576(17)260326(30)5(10)15975568 (box), Lot Number 15975568;
34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260327(10)15979537 (product), (01)10827002114576(17)260327(30)5(10)15979537 (box), Lot Number 15979537;
34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260415(10)16008467 (product), (01)10827002114576(17)260415(30)5(10)16008467 (box), Lot Number 16008467;
35) HNBR5.0-38-100-P-NS-MPB (RPN) G11206 (GPN), UDI: (01)00827002112063(17)260311(10)NS15940015 (product), (01)10827002112060(17)260311(30)5(10)NS15940015 (box), Lot Number NS15940015;
36) HNBR5.0-38-100-P-NS-SHETTY-050181 (RPN) G11475 (GPN), UDI: (01)00827002114753(17)260222(10)NS15912381 (product), (01)10827002114750(17)260222(30)5(10)NS15912381 (box), Lot Number NS15912381;
36) HNBR5.0-38-100-P-NS-SHETTY-050181 (RPN) G11475 (GPN), UDI: (01)00827002114753(17)260222(10)NS15912382 (product), (01)10827002114750(17)260222(30)5(10)NS15912382 (box), Lot Number NS15912382;
37) HNBR5.0-38-100-P-NS-SIM1 (RPN) G08584 (GPN), UDI: (01)00827002085848(17)260327(10)15978552 (product), (01)10827002085845(17)260327(30)5(10)15978552 (box), Lot Number 15978552;
38) HNBR5.0-38-100-P-NS-SIM2 (RPN) G08420 (GPN), UDI: (01)00827002084209(17)260403(10)15988259 (product), (01)10827002084206(17)260403(30)5(10)15988259 (box), Lot Number 15988259;
39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260220(10)15907355 (product), (01)10827002114842(17)260220(30)5(10)15907355 (box), Lot Number 15907355;
39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260307(10)15935929 (product), (01)10827002114842(17)260307(30)5(10)15935929 (box), Lot Number 15935929;
39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260403(10)15988267 (product), (01)10827002114842(17)260403(30)5(10)15988267 (box), Lot Number 15988267;
40) HNBR5.0-38-100-P-NS-VS2 (RPN) G11487 (GPN), UDI: (01)00827002114876(17)260222(10)15912385 (product), (01)10827002114873(17)260222(30)5(10)15912385 (box), Lot Number 15912385;
41) HNBR5.0-38-125-P-NS-H1 (RPN) G11378 (GPN), UDI: (01)00827002113787(17)260408(10)NS15995783 (product), (01)10827002113784(17)260408(30)5(10)NS15995783 (box), Lot Number NS15995783;
42) HNBR5.0-38-125-P-NS-JB2 (RPN) G11883 (GPN), UDI: (01)00827002118836(17)260307(10)NS15937068 (product), (01)10827002118833(17)260307(30)5(10)NS15937068 (box), Lot Number NS15937068;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260308(10)15937663 (product), (01)10827002121703(17)260308(30)5(10)15937663 (box), Lot Number 15937663;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260311(10)15941117 (product), (01)10827002121703(17)260311(30)5(10)15941117 (box), Lot Number 15941117;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260325(10)15972579 (product), (01)10827002121703(17)260325(30)5(10)15972579 (box), Lot Number 15972579;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260404(10)15990981 (product), (01)10827002121703(17)260404(30)5(10)15990981 (box), Lot Number 15990981;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260408(10)15995862 (product), (01)10827002121703(17)260408(30)5(10)15995862 (box), Lot Number 15995862;
43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260408(10)NS15995784 (product), (01)10827002121703(17)260408(30)5(10)NS15995784 (box), Lot Number NS15995784;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260307(10)15936458 (product), (01)10827002116426(17)260307(30)5(10)15936458 (box), Lot Number 15936458;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260311(10)15941118 (product), (01)10827002116426(17)260311(30)5(10)15941118 (box), Lot Number 15941118;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260404(10)15990977 (product), (01)10827002116426(17)260404(30)5(10)15990977 (box), Lot Number 15990977;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260404(10)15990984 (product), (01)10827002116426(17)260404(30)5(10)15990984 (box), Lot Number 15990984;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260405(10)15993149 (product), (01)10827002116426(17)260405(30)5(10)15993149 (box), Lot Number 15993149;
44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260408(10)NS15995785 (product), (01)10827002116426(17)260408(30)5(10)NS15995785 (box), Lot Number NS15995785;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260216(10)15902079 (product), (01)10827002095486(17)260216(30)5(10)15902079 (box), Lot Number 15902079;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260328(10)15980884 (product), (01)10827002095486(17)260328(30)5(10)15980884 (box), Lot Number 15980884;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983218 (product), (01)10827002095486(17)260329(30)5(10)15983218 (box), Lot Number 15983218;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983219 (product), (01)10827002095486(17)260329(30)5(10)15983219 (box), Lot Number 15983219;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983220 (product), (01)10827002095486(17)260329(30)5(10)15983220 (box), Lot Number 15983220;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991907 (product), (01)10827002095486(17)260404(30)5(10)15991907 (box), Lot Number 15991907;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991909 (product), (01)10827002095486(17)260404(30)5(10)15991909 (box), Lot Number 15991909;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991910 (product), (01)10827002095486(17)260404(30)5(10)15991910 (box), Lot Number 15991910;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991911 (product), (01)10827002095486(17)260404(30)5(10)15991911 (box), Lot Number 15991911;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006219 (product), (01)10827002095486(17)260412(30)5(10)16006219 (box), Lot Number 16006219;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006227 (product), (01)10827002095486(17)260412(30)5(10)16006227 (box), Lot Number 16006227;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006228 (product), (01)10827002095486(17)260412(30)5(10)16006228 (box), Lot Number 16006228;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260419(10)16018901 (product), (01)10827002095486(17)260419(30)5(10)16018901 (box), Lot Number 16018901;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260424(10)16027942 (product), (01)10827002095486(17)260424(30)5(10)16027942 (box), Lot Number 16027942;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028949 (product), (01)10827002095486(17)260425(30)5(10)16028949 (box), Lot Number 16028949;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028950 (product), (01)10827002095486(17)260425(30)5(10)16028950 (box), Lot Number 16028950;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028952 (product), (01)10827002095486(17)260425(30)5(10)16028952 (box), Lot Number 16028952;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260426(10)16030430 (product), (01)10827002095486(17)260426(30)5(10)16030430 (box), Lot Number 16030430;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260502(10)16039989 (product), (01)10827002095486(17)260502(30)5(10)16039989 (box), Lot Number 16039989;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260502(10)16039990 (product), (01)10827002095486(17)260502(30)5(10)16039990 (box), Lot Number 16039990;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041716 (product), (01)10827002095486(17)260503(30)5(10)16041716 (box), Lot Number 16041716;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041717 (product), (01)10827002095486(17)260503(30)5(10)16041717 (box), Lot Number 16041717;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041718 (product), (01)10827002095486(17)260503(30)5(10)16041718 (box), Lot Number 16041718;
45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260506(10)16045117 (product), (01)10827002095486(17)260506(30)5(10)16045117 (box), Lot Number 16045117;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260213(10)15895235 (product), (01)10827002084473(17)260213(30)5(10)15895235 (box), Lot Number 15895235;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260305(10)15930790 (product), (01)10827002084473(17)260305(30)5(10)15930790 (box), Lot Number 15930790;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260311(10)15940018 (product), (01)10827002084473(17)260311(30)5(10)15940018 (box), Lot Number 15940018;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260314(10)15947372 (product), (01)10827002084473(17)260314(30)5(10)15947372 (box), Lot Number 15947372;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260318(10)15952568 (product), (01)10827002084473(17)260318(30)5(10)15952568 (box), Lot Number 15952568;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260325(10)15972580 (product), (01)10827002084473(17)260325(30)5(10)15972580 (box), Lot Number 15972580;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260326(10)15975571 (product), (01)10827002084473(17)260326(30)5(10)15975571 (box), Lot Number 15975571;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260328(10)15980163 (product), (01)10827002084473(17)260328(30)5(10)15980163 (box), Lot Number 15980163;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260328(10)15980165 (product), (01)10827002084473(17)260328(30)5(10)15980165 (box), Lot Number 15980165;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260408(10)15995863 (product), (01)10827002084473(17)260408(30)5(10)15995863 (box), Lot Number 15995863;
46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260416(10)16010287 (product), (01)10827002084473(17)260416(30)5(10)16010287 (box), Lot Number 16010287;
47) HNBR5.0-38-65-P-NS-H1 (RPN) G11395 (GPN), UDI: (01)00827002113954(17)260311(10)NS15940007 (product), (01)10827002113951(17)260311(30)5(10)NS15940007 (box), Lot Number NS15940007;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260220(10)15908438 (product), (01)10827002094694(17)260220(30)5(10)15908438 (box), Lot Number 15908438;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260318(10)15952413 (product), (01)10827002094694(17)260318(30)5(10)15952413 (box), Lot Number 15952413;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260321(10)15970067 (product), (01)10827002094694(17)260321(30)5(10)15970067 (box), Lot Number 15970067;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260321(10)15970068 (product), (01)10827002094694(17)260321(30)5(10)15970068 (box), Lot Number 15970068;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260326(10)15977848 (product), (01)10827002094694(17)260326(30)5(10)15977848 (box), Lot Number 15977848;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260327(10)15979424 (product), (01)10827002094694(17)260327(30)5(10)15979424 (box), Lot Number 15979424;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260328(10)15980885 (product), (01)10827002094694(17)260328(30)5(10)15980885 (box), Lot Number 15980885;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260328(10)15980895 (product), (01)10827002094694(17)260328(30)5(10)15980895 (box), Lot Number 15980895;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260329(10)15983223 (product), (01)10827002094694(17)260329(30)5(10)15983223 (box), Lot Number 15983223;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260404(10)15991916 (product), (01)10827002094694(17)260404(30)5(10)15991916 (box), Lot Number 15991916;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260405(10)15993769 (product), (01)10827002094694(17)260405(30)5(10)15993769 (box), Lot Number 15993769;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260410(10)16000849 (product), (01)10827002094694(17)260410(30)5(10)16000849 (box), Lot Number 16000849;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006220 (product), (01)10827002094694(17)260412(30)5(10)16006220 (box), Lot Number 16006220;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006231 (product), (01)10827002094694(17)260412(30)5(10)16006231 (box), Lot Number 16006231;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006232 (product), (01)10827002094694(17)260412(30)5(10)16006232 (box), Lot Number 16006232;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012518 (product), (01)10827002094694(17)260417(30)5(10)16012518 (box), Lot Number 16012518;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012520 (product), (01)10827002094694(17)260417(30)5(10)16012520 (box), Lot Number 16012520;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012523 (product), (01)10827002094694(17)260417(30)5(10)16012523 (box), Lot Number 16012523;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012526 (product), (01)10827002094694(17)260417(30)5(10)16012526 (box), Lot Number 16012526;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260418(10)16014926 (product), (01)10827002094694(17)260418(30)5(10)16014926 (box), Lot Number 16014926;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260502(10)16039993 (product), (01)10827002094694(17)260502(30)5(10)16039993 (box), Lot Number 16039993;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260509(10)16052595 (product), (01)10827002094694(17)260509(30)5(10)16052595 (box), Lot Number 16052595;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260510(10)16054256 (product), (01)10827002094694(17)260510(30)5(10)16054256 (box), Lot Number 16054256;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260510(10)16054257 (product), (01)10827002094694(17)260510(30)5(10)16054257 (box), Lot Number 16054257;
48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260515(10)16061281 (product), (01)10827002094694(17)260515(30)5(10)16061281 (box), Lot Number 16061281;
49) HNBR5.0-38-65-P-NS-LEV2 (RPN) G11207 (GPN), UDI: (01)00827002112070(17)260304(10)NS15928703 (product), (01)10827002112077(17)260304(30)5(10)NS15928703 (box), Lot Number NS15928703;
50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260318(10)15950806 (product), (01)10827002111957(17)260318(30)5(10)15950806 (box), Lot Number 15950806;
50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260328(10)15980164 (product), (01)10827002111957(17)260328(30)5(10)15980164 (box), Lot Number 15980164;
50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260409(10)15997227 (product), (01)10827002111957(17)260409(30)5(10)15997227 (box), Lot Number 15997227;
51) HNBR5.0-38-65-P-NS-MPB (RPN) G11470 (GPN), UDI: (01)00827002114708(17)260311(10)NS15940008 (product), (01)10827002114705(17)260311(30)5(10)NS15940008 (box), Lot Number NS15940008;
52) HNBR5.0-38-65-P-NS-RDC (RPN) G08578 (GPN), UDI: (01)00827002085787(17)260307(10)15936460 (product), (01)10827002085784(17)260307(30)5(10)15936460 (box), Lot Number 15936460;
52) HNBR5.0-38-65-P-NS-RDC (RPN) G08578 (GPN), UDI: (01)00827002085787(17)260318(10)15952569 (product), (01)10827002085784(17)260318(30)5(10)15952569 (box), Lot Number 15952569;
53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260220(10)15907353 (product), (01)10827002100821(17)260220(30)5(10)15907353 (box), Lot Number 15907353;
53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260304(10)15928714 (product), (01)10827002100821(17)260304(30)5(10)15928714 (box), Lot Number 15928714;
53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260314(10)15947373 (product), (01)10827002100821(17)260314(30)5(10)15947373 (box), Lot Number 15947373;
53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260405(10)15993141 (product), (01)10827002100821(17)260405(30)5(10)15993141 (box), Lot Number 15993141;
53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260411(10)16003553 (product), (01)10827002100821(17)260411(30)5(10)16003553 (box), Lot Number 16003553;
54) HNBR5.0-38-65-P-NS-SHK1.0 (RPN) G11476 (GPN), UDI: (01)00827002114760(17)260319(10)15953573 (product), (01)10827002114767(17)260319(30)5(10)15953573 (box), Lot Number 15953573;
55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260408(10)15995864 (product), (01)10827002086774(17)260408(30)5(10)15995864 (box), Lot Number 15995864;
55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260409(10)15997228 (product), (01)10827002086774(17)260409(30)5(10)15997228 (box), Lot Number 15997228;
55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260416(10)16010286 (product), (01)10827002086774(17)260416(30)5(10)16010286 (box), Lot Number 16010286;
56) HNBR5.0-38-65-P-NS-SIM2 (RPN) G08625 (GPN), UDI: (01)00827002086258(17)260216(10)15901240 (product), (01)10827002086255(17)260216(30)5(10)15901240 (box), Lot Number 15901240;
56) HNBR5.0-38-65-P-NS-SIM2 (RPN) G08625 (GPN), UDI: (01)00827002086258(17)260307(10)15936461 (product), (01)10827002086255(17)260307(30)5(10)15936461 (box), Lot Number 15936461;
57) HNBR5.0-38-65-P-NS-SIM3 (RPN) G08849 (GPN), UDI: (01)00827002088498(17)260201(10)NS15877682 (product), (01)10827002088495(17)260201(30)5(10)NS15877682 (box), Lot Number NS15877682;
58) HNBR5.0-38-65-P-NS-VS1 (RPN) G11486 (GPN), UDI: (01)00827002114869(17)260222(10)15912384 (product), (01)10827002114866(17)260222(30)5(10)15912384 (box), Lot Number 15912384;
59) HNBR5.0-38-80-P-NS-C1 (RPN) G11203 (GPN), UDI: (01)00827002112032(17)260328(10)15980162 (product), (01)10827002112039(17)260328(30)5(10)15980162 (box), Lot Number 15980162;
60) HNBR5.0-38-80-P-NS-CHG2.5 (RPN) G11430 (GPN), UDI: (01)00827002114302(17)260304(10)15928715 (product), (01)10827002114309(17)260304(30)5(10)15928715 (box), Lot Number 15928715;
61) HNBR5.0-38-80-P-NS-CHG3 (RPN) G13573 (GPN), UDI: (01)00827002135734(17)260311(10)NS15940017 (product), (01)10827002135731(17)260311(30)5(10)NS15940017 (box), Lot Number NS15940017;
62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260220(10)15907354 (product), (01)10827002093123(17)260220(30)5(10)15907354 (box), Lot Number 15907354;
62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260227(10)15919325 (product), (01)10827002093123(17)260227(30)5(10)15919325 (box), Lot Number 15919325;
62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260403(10)15988260 (product), (01)10827002093123(17)260403(30)5(10)15988260 (box), Lot Number 15988260;
62) HNBR5.0-38-80-P-NS-MIK (RPN) G09312 (GPN), UDI: (01)00827002093126(17)260411(10)16003544 (product), (01)10827002093123(17)260411(30)5(10)16003544 (box), Lot Number 16003544;
63) HNBR5.0-38-80-P-NS-MPB (RPN) G11469 (GPN), UDI: (01)00827002114692(17)260320(10)15957909 (product), (01)10827002114699(17)260320(30)5(10)15957909 (box), Lot Number 15957909;
64) HNBR5.0-38-80-P-NS-RLG (RPN) G27853 (GPN), UDI: (01)00827002278530(17)260402(10)15985664 (product), (01)10827002278537(17)260402(30)5(10)15985664 (box), Lot Number 15985664;
65) HNBR5.0-38-80-P-NS-VS1 (RPN) G11189 (GPN), UDI: (01)00827002111899(17)260201(10)15879283 (product), (01)10827002111896(17)260201(30)5(10)15879283 (box), Lot Number 15879283;
65) HNBR5.0-38-80-P-NS-VS1 (RPN) G11189 (GPN), UDI: (01)00827002111899(17)260216(10)15901235 (product), (01)10827002111896(17)260216(30)5(10)15901235 (box), Lot Number 15901235;
66) HNBR5.0-38-80-P-NS-VS2 (RPN) G11190 (GPN), UDI: (01)00827002111905(17)260201(10)15879284 (product), (01)10827002111902(17)260201(30)5(10)15879284 (box), Lot Number 15879284;
66) HNBR5.0-38-80-P-NS-VS2 (RPN) G11190 (GPN), UDI: (01)00827002111905(17)260220(10)15907358 (product), (01)10827002111902(17)260220(30)5(10)15907358 (box), Lot Number 15907358. |
Recalling Firm/
Manufacturer |
Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact | Cook Medical Customer Relations Department
800-457-4500 |
|---|
Manufacturer Reason
for Recall | Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. |
|---|
FDA Determined
Cause 2 | Process change control |
|---|
| Action | Cook Medical issued an URGENT: MECIAL DEVICE RECALL notice to its consignees on 05/15/2025 via Fed-Ex Standard Overnight mail. The notice explained the reason for the recall, risk to health, and requested the following actions be taken:
"Actions to be Taken by the Customer
1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products.
2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions.
3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com).
4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred.
5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com."
For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
The firm issued an updated notice on 05/22/2025 with the updated UDIs for each product. |
|---|
| Quantity in Commerce | 26986 units |
|---|
| Distribution | Worldwide distribution. |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = DQO
|
|---|
|
|
|
