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Devices
Device Recall Convenience Kit. Inflation Custom Kit
Model / Serial
Lot # A286536 # A286573 #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538 #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616 #A284618, #A286535, #A286547, #A284998 #A284694, #A284617, #A286560, #A286542 #A286550, #A287554, #A287553, #A279791 #A290033, #A290053, #A286541, and #A283067.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Product Description
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, || K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
Manufacturer
Merit Medical Systems, Inc
1 Event
Recall of Device Recall Convenience Kit. Inflation 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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