Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-0607-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

Product Classification:

Class II

Date Initiated: November 30, 2015

Date Posted: January 13, 2016

Recall Number: Z-0607-2016

Event ID: 72787

Reason for Recall:

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

Status: Terminated

Product Quantity: 77,136 units

Code Information:

Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534

Distribution Pattern:

US Nationwide Distribution and the country of Canada

Voluntary or Mandated:

Voluntary: Firm initiated