Add-A-Vial II Binary Connector

• 2 recalls, same reason

  • Terminated Z-0424-2014 FDA Class II ·initiated 4 Apr 2013
  • Terminated Z-0425-2014 FDA Class II ·initiated 4 Apr 2013

  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

510(k) Number

K900865 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K905611 Active Cleared 1 Mar 1991

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