Baxter CLEARLINK Blood Bag Spike Adapter Recalled for Particulate Matter
Baxter Healthcare is recalling CLEARLINK Blood Bag Spike Adapters due to potential dark loose particulate matter on the spike.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Baxter Healthcare Corp. is recalling the CLEARLINK System Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access (catalog number 1C8687). The recall involves 77,136 units distributed nationwide in the United States and in Canada. The affected lot numbers are GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534.
The recall was initiated because of the potential for dark loose particulate matter, measuring 400 microns or smaller, to be present on the spike of the spike adapter or solution set. This product is an accessory used to transfer a medicinal product from one container to another.
Healthcare facilities and consumers should stop using the affected products and contact Baxter Healthcare Corp. for instructions on how to return the items or obtain a replacement.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 77,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: GR323907
- GR324806
- GR326116
- GR326645
- GR327528
- and GR328534
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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