Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
FDA device recall Z-0205-06 · posted 2005-11-29 · Terminated
Recall details
- Recalling firm
- Namsa
- Reason for recall
- The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 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
- Date initiated
- 2005-03-18
- Date posted
- 2005-11-29
- Date terminated
- 2012-04-12
- Location
- Northwood, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR (K994381) | Raven Biological Laboratories, Inc. | 2001-03-30 |