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Cardinal Health has issued a worldwide recall for 201,000 misassembled Alaris pump modules distributed since September.

The recall applies to all model 8100 devices (formerly known as Medley pump modules) that were distributed to 46 states, the District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia.

Bent, broken, nested, or missing occluder springs in the module could cause medication overinfusion and potentially fatal adverse events, according to an alert sent from MedWatch, the Food and Drug Administration's safety information and adverse event reporting program.

According to Cardinal Health recall information, 1 injury and 2 deaths have been reported with use of the device.

Furthermore, intermittent functioning of the misassembled springs may render overinfusion difficult to detect. Because the occluder pressure test may not detect all misassembled springs, a company inspection is required.

The company is working to inspect and repair devices at their service facility and has dispatched field teams to customer sites. Substitute pump modules are available for loan to hospitals during this process.

Devices shipped by the manufacturer after September 27 were subjected to a new assembly inspection process and are not affected by the recall.

Additional information concerning the recall may be obtained by contacting the company.

Reference:

"Cardinal Recalls More Than 200,000 Alaris Pump Modules," medscape.com, Yael Waknine, December 2007.