Devices

Device Recall Hemodialysis System and Accessories

Model / Serial
Lot Numbers: 110914F7, 110920F2
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
Product Description
Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" || Ref. Number: D9-2007MG. || Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector.
Manufacturer
Medisystems Corp
1 Event
- Recall of Device Recall Hemodialysis System and Accessories

Manufacturer

Medisystems Corp

Manufacturer Address
Medisystems Corp, 439 S Union St Fl 5th, Lawrence MA 01843-2837
Manufacturer Parent Company (2017)
Nxstage Medical Inc
Source
USFDA

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