FDA Medical Device Recalls (openFDA)
Namsa: Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
- Recall number
- Z-0205-06
- Recalling firm
- Namsa
- Product
- Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
- Status
- Terminated
- Initiated
- 2005-03-18
- Posted
- 2005-11-29
- Terminated
- 2012-04-12
- Reason
- The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
- 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
- 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
- Lot, serial or model codes
- lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.
- 510(k) numbers
- ["K994381"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 1521876
- Firm city
- Northwood
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28