Devices

Device Recall Integra Suction Reservoir with AntiReflux Valve

Model / Serial
Catalog number: 910-500: lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155. Catalog number: 31223; lot numbers 158817, 156484. 157140, 157345, 156618; Catalog number: 31253: lot numbers: 158817, 156484, 157345, 158690, 156618.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka.
Product Description
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; || Sterile, Rx only. || Manufactured by Integra NeuroSciences Implants S.A., || Sophia Antipolis Cedex, France; || distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; || This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.
Manufacturer
Integra LifeSciences Corp.
1 Event
- Recall of Device Recall Integra Suction Reservoir with AntiReflux Valve

Manufacturer

Integra LifeSciences Corp.

Manufacturer Address
Integra LifeSciences Corp., 311 Enterprise Dr, Plainsboro NJ 08536-3344
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

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