Recall Z-0205-06 ยท FRC Indicator, Biological Sterilization Process
Namsa
Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
| Date | Nov 29, 2005 (initiated Mar 18, 2005) |
| Status | Terminated |
| 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: Ste |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR Raven Biological Laboratories, Inc., Mar 30, 2001 |