Baxter Recalls Arthroscopic Irrigation Sets Due to Packaging Pinholes
Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
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 is a potential compromise of the sterile barrier due to packaging defects. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets (Product Code 2C4031) used with ARTHROMATIC Plastic Containers. The recall involves 249,576 units that were distributed nationwide in the United States.
The recall was initiated after an internal investigation discovered pinholes in the product packaging. These pinholes are unlikely to be detected by end users prior to use and could compromise the sterile barrier properties of the packaging, potentially affecting the sterility of the irrigation sets.
Healthcare providers and facilities should check their inventory for the affected product codes listed in the recall notice. If the product is found, it should be removed from use and returned to Baxter Healthcare Corp. or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (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
- 249,576
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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