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U.S. Department of Health and Human Services

Class 2 Device Recall MultiCut Block Mold Cutter System, Version 1.2

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 Class 2 Device Recall MultiCut Block Mold Cutter System, Version 1.2see related information
Date Initiated by FirmNovember 10, 2002
Date PostedSeptember 13, 2003
Recall Status1 Terminated 3 on December 12, 2003
Recall NumberZ-0985-02
Recall Event ID 27148
510(K)NumberK964167 
ProductBlock Mold Cutter, Model 8532, Version 1.2.
Code Information Serial numbers 20128306, 23073201, 21118501, 20023201, 21118502, 21033201, 20028306, 23093201, 22083201, and 20093201
FEI Number 1938060
Recalling Firm/
Manufacturer		 Multidata Systems Intl Corp
9801 Manchester Rd
St Louis MO 63119
For Additional Information ContactMr. Arne Roestel
314-968-6880
Manufacturer Reason
for Recall		The units lacked the required labels per the laser performace standard.
FDA Determined
Cause 2		Other
Quantity in Commerce10 units
DistributionDistribution was made to SC, FL, GA, NY, PA, NC, IL, and NJ.
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.
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