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Devices
Device Recall Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Site
Model / Serial
Lot #'61030997 with an expiration date of 12/31/2013 and Lot #'s 61031000, 61031001, 61031002, and 61031004 with an expiration date of 1/31/2014.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA and Canada.
Product Description
Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. || For use with Secondary Container.
Manufacturer
B. Braun Medical, Inc.
1 Event
Recall of Device Recall Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Site
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Manufacturer
B. Braun Medical, Inc.
Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
Language
English
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