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Cordis Corporation Recall 87329

Description: PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

Cordis Corporation Recall 87329 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1257-2021
Event ID87329
Event DescriptionPRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
Product TypeDevices
DistributionUS (except MT and NM) and Taiwan
Quantity18218 units
Recall ReasonDistal tip may become separated from the lumen wire in specific lots.
Device Classification20210324
Device Code Info1. PC0520RXC, Lot Numbers: 17917082, 17925698, 17945241, 17946961 2. PC0530RXC, Lot Numbers: 17907242, 17915157, 17931757, 17936915, 17940306, 17945490, 17950283, 17952939 3. PC0540RXC, Lot Numbers: 17907243, 17911879, 17920422, 17931758, 17942800, 17945242, 17947078, 17950284, 17955963, 17960311 4. PC0620RXC, Lot Numbers: 17917084, 17920423, 17931102, 17949017, 17955964 5. PC0630RXC, Lot Numbers: 17910548, 17914196, 17915158, 17921807, 17937805, 17939529, 17945243, 17945883, 17949018, 17957289 6. PC0640RXC, Lot Numbers: 17903563, 17908608, 17912281, 17916478, 17928282, 17934629, 17936243, 17939530, 17946675, 17950285, 17958864, 17961560 7. PC0720RXC, Lot Numbers: 17929124, 17933386 8. PC0730RXC, Lot Numbers: 17909814, 17916479, 17925699, 17929770, 17935168, 17940238, 17941419, 17949346, 17951255, 17951944, 17954156, 17959599 9. PC0740RXC, Lot Numbers: 17905295, 17915162, 17920425, 17922174, 17926320, 17935169, 17936920, 17937807, 17940240, 17941874, 17941875, 17956888, 17959601, 17962539 10. PC0820RXC, Lot Numbers: 17905297, 17919723, 17942803, 17945491 11. PC0830RXC, Lot Numbers: 17910553, 17916481, 17919724, 17928285, 17931762, 17934630, 17936244, 17939531, 17945884, 17945885, 17949962, 17955967, 17959602 12. PC0840RXC, Lot Numbers: 17904654, 17907246, 17910556, 17912285, 17913915, 17918979, 17918980, 17920427, 17921809, 17924451, 17926321, 17928286, 17929771, 17931763, 17933387, 17935170, 17936245, 17936922, 17936923, 17941421, 17941422, 17941876, 17941877, 17947267, 17947268, 17948772, 17949964, 17951256, 17958217, 17959603, 17961226 13. PC0920RXC, Lot Numbers: 17949965 14. PC0930RXC, Lot Numbers: 17906531, 17914902, 17929126, 17934632, 17941424, 17945244, 17946676, 17946963, 17960312 15. PC0940RXC, Lot Numbers: 17907250, 17912290, 17914198, 17916482, 17917085, 17919725, 17928287, 17931103, 17935173, 17936247, 17939532, 17940242, 17945886, 17950287, 17955668 16. PC1030RXC, Lot Numbers: 17911881, 17913484, 17918070, 17934633, 17940243, 17947080 17. PC1040RXC, Lot Numbers: 17913485, 17917086, 17917087, 17917088, 17920429, 17927599, 17929128, 17931104, 17934634, 17935176, 17936248, 17940244, 17940245
Center Classification Date20210315
Recall Initiation Date20210211
Recalling FirmCordis Corporation
Initial Notification Letter
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