Namsa Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
Brand
Namsa
Lot Codes / Batch Numbers
lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.
Products Sold
lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.
Namsa is recalling Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. due to The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NH, NJ, OH, WA
Page updated: Jan 10, 2026