FDA Device

Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.

Hazard

The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.

What You Should Do

Remedy

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.

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Products

Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
Brand
Namsa
UPC
lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.

Units Affected

lot 643: 10/50 kit boxes; lot 674: 39 boxes.

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