Devices

Device Recall 10 cc NonSterile Syringe

Model / Serial
Reorder #: 00-093207 - Lot #: 99442547
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
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: || Product Label || ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' || Carton Label || ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***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 10 cc 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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