Precise PRO recall
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC…
Why was Precise PRO recalled?
Distal tip may become separated from the lumen wire in specific lots.
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?
1. 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
- Product
- PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC…
- Recalling firm
- Cordis Corporation
- Quantity
- 18218 units
- Distribution
- US (except MT and NM) and Taiwan
- Recall date
- March 24, 2021
- Classification
- Class I
- Status
- Completed
- Agency
- FDA (device)