Baxter Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-0194-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Product Classification:

Class II

Date Initiated: October 6, 2015

Date Posted: November 11, 2015

Recall Number: Z-0194-2016

Event ID: 72362

Reason for Recall:

Leakage from the inlet port of the 15L Cycler Drainage Bags.

Status: Terminated

Product Quantity: 19,440 units

Code Information:

H15C11095

Distribution Pattern:

US Distribution and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated