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Devices
Device Recall Convenience Kit
Model / Serial
Lot Numbers: H959038, H970334, H984351.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Product Description
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Manufacturer
Merit Medical Systems, Inc.
1 Event
Recall of Device Recall Convenience Kit
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Manufacturer
Merit Medical Systems, Inc.
Manufacturer Address
Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
Manufacturer Parent Company (2017)
Merit Medical Systems Inc.
Source
USFDA
3 devices with a similar name
Learn more about the data
here
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
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
Device Recall Convenience Kit. Waste Collection kit.
Model / Serial
Lot # A289183
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Product Description
Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K10-01047.
Manufacturer
Merit Medical Systems, Inc
Language
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