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U.S. Department of Health and Human Services

Class 2 Device Recall Self Contained Biological Indicator.

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 Class 2 Device Recall Self Contained Biological Indicator.see related information
Date Initiated by FirmMarch 18, 2005
Date PostedNovember 29, 2005
Recall Status1 Terminated 3 on April 12, 2012
Recall NumberZ-0205-06
Recall Event ID 31560
510(K)NumberK994381 
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
ProductSelf Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
Code Information lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.
FEI Number 1521876
Recalling Firm/
Manufacturer		 Namsa
6750 Wales Rd
Northwood OH 43619-1012
For Additional Information ContactMatthew Sliva
419-666-9455 Ext. 331
Manufacturer Reason
for Recall		The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
FDA Determined
Cause 2		Other
ActionThe 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 Commercelot 643: 10/50 kit boxes; lot 674: 39 boxes.
DistributionDomestic 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = FRC
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