FDA-Device2013-12-04Class II
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
B. Braun Medical, Inc.
Hazard
Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i
Sold states
Nationwide Distribution
Affected count
1,746,079 units
Manufactured in
901 Marcon Boulevard, N/A, Allentown, PA, United States
Products
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0424-2014Don't want to check this manually?
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