FDA
Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
The firm contacted consignees by phone on or about 3/18/05 and sent a follow up letter on or about 3/31/05. Consignees are asked to contact their customers if they further distributed the product.