Baxter Arthroscopic Irrigation Sets Recalled Due to Packaging Pinholes
Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
What this means for you
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 source text describes a theoretical risk to the sterile barrier without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Baxter Healthcare Corp. is recalling approximately 530,488 units of Two Lead Arthroscopic Irrigation Sets (Product Code 2C4030) distributed nationwide in the United States. The recall was initiated after an internal investigation discovered pinholes in the product packaging.
The pinholes are not likely to be detected by the end user prior to use. Their presence could compromise the sterile barrier properties of the packaging, potentially affecting the sterility of the irrigation sets intended for use during bladder irrigation or endoscopic procedures.
The recalled product
- Product
- Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 530,488
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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