FDA-Device2021-03-24Class I
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
Hazard
Distal tip may become separated from the lumen wire in specific lots.
Sold states
US (except MT and NM) and Taiwan
Affected count
18218 units
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2021Don't want to check this manually?
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