Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recallsee related information
Date Initiated by FirmFebruary 25, 2003
Date PostedApril 09, 2003
Recall Status1 Terminated 3 on May 17, 2004
Recall NumberZ-0712-03
Recall Event ID 25811
510(K)NumberK922481 
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
ProductGluteraldehyde 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.
FEI Number 3001168737
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
ActionNotice 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 Commerce4,112 cases of two bottles each. 60 strips per bottle.
DistributionNationwide and Canada.
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 = JOJ
-
-