Recall Z-0607-2016— Baxter Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-11-30, terminated 2016-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set..
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-30
- Terminated
- 2016-10-30
- Firm location
- Deerfield, IL, United States
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.
Reason for recall
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Data sourced from openFDA. This site is unofficial and independent of the FDA.