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Devices
Device Recall Convenience Kit. Manifold Custom Kit
Model / Serial
Lot # A279212, #A28360, #A286211, #A282726 #A281641, #A279931, #A282796, #A288051, #A285173, #A284256, and #A290244.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Product Description
Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-00970J, || #K09-06383B, #K09-07002A, #K09-04734D, || #K09-00794K, and #K09-08037A.
Manufacturer
Merit Medical Systems, Inc
1 Event
Recall of Device Recall Convenience Kit. Manifold Custom Kit
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Manufacturer
Merit Medical Systems, Inc
Manufacturer Address
Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
Source
USFDA
Language
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