FDA-Device2018-06-20Class II
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up t
Datascope Corporation
Hazard
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Sold states
The products were distributed to the following US states: IA and FL.
Affected count
8
Manufactured in
15 Law Dr, N/A, Fairfield, NJ, United States
Products
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2180-2018Don't want to check this manually?
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