B. Braun Medical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0425-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 4, 2013

Date Posted: December 4, 2013

Recall Number: Z-0425-2014

Event ID: 65356

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,000 units

Code Information:

Material BC1300, Lot number 61286479.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated