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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm February 25, 2003
Date Posted April 09, 2003
Recall Status1 Terminated 3 on May 17, 2004
Recall Number Z-0712-03
Recall Event ID 25811
510(K)Number k922481  
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
Product Gluteraldehyde Concentration Indicators.

MetriTest 1.5% and MetriTest 1.8%, also
OmniChek 1.5% and OmniCheck 1.8%
Code Information MetriTest 1.5%, part number 10-303, lot numbers: 007917, 007919, 008184, 008325, 008665, 009100. MetriTest 1.8%, part number 10-304, lot numbers: 009101, 009121, 009144, 009249.  OmniChek G 1.5%, part number 10-313, lot 009091. OmniChek G 1.8%, part number 10-313, lot 009102.
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 West Collins Avenue
Orange CA 92867
Manufacturer Reason
for Recall		 Moisture ingress into packaging of test strips may cause premature failure.
FDA Determined
Cause 2		 Other
Action Notice was sent to customers of the potential problem on 3/7/2003. The notice included directions to perform a Modified Quality Control Procedure. Instructions are to test strips function each day.
Quantity in Commerce 4,112 cases of two bottles each. 60 strips per bottle.
Distribution Nationwide and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JOJ and Original Applicant = BOARD OF DIRECTORS, ALBERT BROWNE LTD.
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