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Terminated

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

FDA Recall Z-0205-06 · Posted 2005-11-29

Recalling FirmNamsa
Recall StatusTerminated
Product CodeFRC
Date Initiated2005-03-18
Date Terminated2012-04-12
Product Quantitylot 643: 10/50 kit boxes; lot 674: 39 boxes.

Reason for Recall

The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K994381PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATORRaven Biological Laboratories, Inc. · 2001-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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