Devices

Crossover Reinforced Catheter Introducer System

Model / Serial
Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
United States (FL and MN).
Product Description
Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Manufacturer
Thomas Medical Products Inc
1 Event
- Recall of Crossover Reinforced Catheter Introducer System

Manufacturer

Thomas Medical Products Inc

Manufacturer Address
Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
Source
USFDA

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