FDA Device recall Z-0607-2016
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to trans…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to trans… by Baxter Healthcare, citing potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0607-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-30 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2016%22
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