FDAFDA · Food and drugs·Recall number Z-1241-2022
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520
Published June 15, 2022 · Recall initiated: May 5, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot
- Lots: 14445809 NS14440413 14438720 NS14533529 NS14531987 NS14512935 NS14531991 NS14531985 NS14531989 NS14531990 NS14531993 NS14531994 14230667 14219518 14228061 14232591 14233388 14233393 14280197 14299971 14239561 14239563 14240096 14227837 14231033 14231052 14232846 14318778 14343805 NS14318613 NS14345341 14325852 14366728 NS14341560 NS14345338 NS14345796 14317075 14366729 14395251 14446172 14452759 14461634 14542803 14542804 14542805 NS14533531 14502814 14233390 14223991 14280196 14299968 14299969 14228357 14240093 14240095 14240097 14242960 14280193 14280194 NS14242956 NS14267436 NS14285103 NS14285105 NS14285113 NS14285116 NS14285118 14343806 14343808 14401670 14560261 14242333 14242961 14244909 14230666 14231051 14231480 14236762 14239564 14240094 14242899 14280195 14244951 14340480 14343008 14363296 NS14329321 14363792 14371377 14392159 14557484 14558691 14560262 14244907 14239562 14303167 14303168 14233392 14244908 14387092 14391580 14368792 14394030 14404724 14411527 14411533 NS14393837 14392161 14310711 14392479 NS14401834 14393836 14394139 14407670 NS14411530 14392162 14395248 14395250 14401669 14404664 14458554 14469137 14461546 14557483 14560260 14568246 14324499 14324561 14329743 NS14357214 14368791 14405012 14404722 14407669 14407731 14444295 14445814 14459064 14239565 14248731 14270214 14230668 14231034 14232592 14299970 NS14280198 14343807 14329319 14363297 14329744 14329746 14356323 NS14354206 NS14356996 NS14356998 NS14357000 NS14357208 NS14357211 14329738 14334099 NS14458938 14458553 14438764 14459660 14460713 NS14445808 14117167 NS14204660 NS14204661 14264718 14317112 14322914 14314095 14354105 14354308 NS14345792 NS14354207 NS14356995 NS14357209 NS14357216 14331801 14345342 14395165 14329353 14461977 14461477 14461828 14427826 14443855 14461633 14464822 14492202 14493151 14493152 14248725 14248726 14259109 14264230 14261712 14275595 14341563 NS14357210 14329745 14333908 14396081 14399139 14338855 14343042 14345340 14329742 14438721 14450442 14461547 14440430 14459065 14568247 14568247 14295067 NS14285117 NS14329737 NS14331626 14329320 14333886 14377708 NS14357207 14381297 14399140 14466958 14472466 14460714 14492201 14531047 14531984 14568248 14571878 14571880 14574880 14574881 14513458 NS14219519 14204662 14204670 14204671 NS14204659 NS14221709 NS14222394 NS14222395 NS14224135 14244953 NS14331628 14278732 14408758 NS14411445 NS14411451 NS14411458 NS14418475 NS14420111 14411430 14204669 NS14221710 NS14221711 NS14222393 NS14224732 NS14224733 NS14227161 14204831 NS14222396 14244906 14270212 NS14331627 14275593 14295066 14336480 14354205 14392480 14406553 14407581 14408760 14410615 14411443 14414399 14410985 14423203 14410614 14411462 NS14227159 14368790 14427825 14501828 14501829 14427592 14427824 14466959 14470990 14472464 14472465 14468751 14492203 14571879 14574882 14530352 14541815 14513459 14515399 14516002 14516654 14526502 14530353 14531046 14541814 14542035 14532062 14221708 14323043 14327107 14341564 14345339 14336479 14343007 14473168 14469795 14471408 14515400 14516655 14515996 14533527 14533528 14537554 14539480 14531986 14537553 14542040 14545259 14276060 14275594 14278731 14285684 14290348 14411526 14343009 14333907 14356324 NS14411535 NS14411547 NS14411552 NS14411554 14571883 14551461 NS14581367 NS14589845 NS14589846 NS14589849 NS14589850 NS14589852 NS14589853 NS14589854 14402618 14418585 14418586 14345791 14345793 14345788 14350205 14345789 14352728 14356322 14345787 14348032 14359695 14354310 14356327 NS14379763 14401830 14414400 14413821 14420112 14407730 14409288 14501831 14539894 14438763 14516001 NS14571882 NS14574879 NS14577031 NS14577032 14602397 14542065 14545258 14545260 NS14589847 14345786 NS14411553 14360272 14363791 14368403 14395249 14404900 14413823 14411426 14426440 14426612 14427591 14427841 14434086 14433107 14408759 14418479 14433108 NS14531992 NS14533530 14467172 14473216 14539190 NS14572219 14539479 14545463 14545607 14411425 14427842 14432995 14404721 14431270 14432995 14
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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