Baxter CLEARLINK Extension Set Recalled for Packaging Pinholes
Baxter Healthcare is voluntarily recalling 3,200 units of CLEARLINK Extension Sets due to potential pinholes in the packaging that could breach the sterile barrier.
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 a voluntary precautionary measure for a potential sterile barrier breach (pinholes) with no reported illnesses or injuries, fitting the criteria for a moderate severity rating.
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary recall of 3,200 units of the CLEARLINK System Non-DEHP Three Lead Extension Set. The affected product is a sterile, nonpyrogenic medical device used with vascular access devices for the administration of drugs and solutions.
The recall is being conducted due to the potential for pinholes in the packaging. These pinholes represent a breach in the sterile barrier, which could lead to potential contamination of the device.
The affected units were distributed in the United States, specifically in the states of Oklahoma, Georgia, California, Minnesota, Texas, and Hawaii. The product codes associated with this recall are UR13C11089 and UR13D16060.
The recalled product
- Product
- Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and…
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Vascular Access
- Affected units
- 3,200
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 (2)
- UR13C11089
- UR13D16060
Distribution
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