Devices

Device Recall 12cc Nonsterile syringe

Model / Serial
Reorder #: 00-093209 - Lot #: 99440951 Reorder #: 00-093209 - Lot #: 99443816 Reorder #: 00-093211 - Lot #: 99443819
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Product Description
Labeling is as follows: || Product Labeling: || ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended******1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' || Carton Labeling: || ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
Manufacturer
Argon Medical Devices, Inc
1 Event
- Recall of Device Recall 12cc Nonsterile syringe

Manufacturer

Argon Medical Devices, Inc

Manufacturer Address
Argon Medical Devices, Inc, 1445 Flat Creek Rd, Athens TX 75751-5002
Manufacturer Parent Company (2017)
RoundTable Healthcare Partners Lp
Source
USFDA

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