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.
FDA Recall Z-0607-2016 · Posted None
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeNEP
Date Initiated2015-11-30
Date Terminated2016-10-30
Product Quantity77,136 units
Reason for Recall
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution and the country of Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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