FDA recalls blood cell separation device component

Fresenius Kabi LLC has issued a recall of red blood cell exchange sets used on AS104 blood cell separation devices, according to an FDA release.

The recall occurred because the affected lots were found to remove greater amounts of red blood cells than intended, resulting in hemodilution.

The class 1 recall was initiated on Oct. 18, 2010 for Red Blood Cell Set lot numbers WKT252, YLT061, ZCT011 and ZGT052, which were manufactured from Oct, 1, 2007 to July 30, 2010. There are 255 units subject to the recall.

Fresenius issued a Field Safety Corrective Action letter to customers in the US on Oct. 18. The letter was followed up with telephone calls during which customers were advised to examine inventory to locate possible affected products. The company instructed customers to halt distribution, dispensation and use of any affected products, and to return those products to Fresenius headquarters.

Customers also were instructed to notify sub-account customers that the recall had occurred. All parties involved are encouraged to complete a Product Recall Response Form.

The product is used for depletion or exchange of red blood cells during therapeutic aphaeresis procedures.

The FDA noted that “class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the press release.

Health care professionals and consumers are encouraged to report adverse events or quality issues with the product to the MedWatch Adverse Event Reporting program.

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