Z-0205-06

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

Name: Z-0205-06 Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674
Creator: Namsa
Published: 2005-03-18
License: https://open.fda.gov/license/

Namsa / initiated 2005-03-18 / Terminated

FDA source

Namsa began a recall of Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674 on 2005-03-18. The reason FDA records is "The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0205-06
Status: Terminated
Initiated: 2005-03-18
Posted: 2005-11-29
Terminated: 2012-04-12
Recalling firm: Namsa
Product: Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
FDA root cause: Other
Action: 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.
Quantity in commerce: lot 643: 10/50 kit boxes; lot 674: 39 boxes.
Distribution: Domestic accounts: SRI International, 333 Ravenswood, Menlo Park, CA 94025; NAMSA, 6750 Wales, Northwood, OH 43619; Smiths Medical ASD, Inc., 10 Bauman Drive, Keene, NH 03431; Medisystems, 701 Pike St., Seattle, WA 98101; Inverness, 17-10 Willow St., Fairlawn, NJ 07410; International Accounts: Sterisure Associates, Shop No-2 Parachawl, Jijama, Pump House Mumbai India; Biomedical Research and Support Services (BRASS), 59 Ubi Ave., #06-04 Bizlink Center, Singapore 65 67426007
Product codes and lots: lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.

Product code FRC

K994381Class IIProspore2 Self-Contained Biological IndicatorRaven Biological Laboratories, Inc. / cleared 2001-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)