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Devices
Device Recall 10 cc Sterile Custom Manifold Kit
Model / Serial
Reorder #: 00-194902A - Lot #: 99444872
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***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing Set***1 Zero Port Plug, Serrated***1 Monitor Line Labels***STERILE EO***STERILIZED BY EtO***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' || Carton Labeling: || ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***Quantity: 10 ea***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
Manufacturer
Argon Medical Devices, Inc
1 Event
Recall of Device Recall 10 cc Sterile Custom Manifold Kit
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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
Language
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