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Devices
Device Recall 10cc Nonsterile Manifold Kit
Model / Serial
Reorder #: 00-094337 - Lot #: 99442306 Reorder #: 00-094367 - Lot #: 99443999 Reorder #: 00-094367 - Lot #: 99444179
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***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or repacking.***1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' || Carton Labeling: || ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***Quantity: 20 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 10cc Nonsterile 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
English
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