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B. Braun Medical, Inc. recalls 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for f
Recalled December 4, 2013 · FDA recall Z-0425-2014 · B. Braun Medical
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 · FDA Class II
Units
4,000 units
Sold at
Nationwide Distribution
Description
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
Product
13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Manufacturer(s)
B. Braun Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →