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-NEST
Check against the official notice below — it lists the full affected range.
Cook Incorporated is recalling Nester Embolization Microcoil devices due to a manufacturing defect where the loading cartridges included with these devices may contain a small, unintended stainless-steel cannula. The recall affects 106,033 units that were distributed nationwide in the United States and worldwide internationally, across multiple lot numbers.
The recall record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Reason for recall: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 106,033 Lot/code info: 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 14
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.