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.
Reported: January 13, 2016 Initiated: November 30, 2015 #Z-0607-2016
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 77,136 units
- Distribution
- US Nationwide Distribution and the country of Canada
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: 77,136 units.
Why was this product recalled? ▼
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0607-2016.
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