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.
This recall has been terminated (originally issued November 30, 2015).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- November 30, 2015
- Terminated
- October 30, 2016
- Recall Number
- Z-0607-2016
- Quantity
- 77,136 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Distribution
US Nationwide Distribution and the country of Canada
Lot / Code Info
Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534
Root Cause
Under Investigation by firm
Action Taken
Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.