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U.S. Department of Health and Human Services

Class 2 Device Recall TissueTek PARAFORM PROC/EMB/MEDIUM

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  Class 2 Device Recall TissueTek PARAFORM PROC/EMB/MEDIUM see related information
Date Initiated by Firm April 16, 2014
Date Posting Updated June 10, 2014
Recall Status1 Terminated 3 on September 02, 2014
Recall Number Z-1748-2014
Recall Event ID 68081
Product Classification Formulations, paraffin, all - Product Code KEO
for diagnostic chemistry use.
Sakura Finetek USA, Inc.
Code Information Product Code: 7052., Lot Number: 263922.
Recalling Firm/
Sakura Finetek USA Inc
1750 W 214th St
Torrance CA 90501-2857
For Additional Information Contact
Manufacturer Reason
for Recall
This Lot has variations in melting temperature.
FDA Determined
Cause 2
Packaging process control
Action Customer notifications sent via e-mail letter. The letter titled "PRODUCT RECALL" dated 04/17/2014 informed customers (of Lot 263922), informed customers of the recall by providing the following information: product name, code, lot number, reason for recall, requested actions, contact information and an "FIELD CORRECTION EFFECTIVENESS CHECK" form.
Quantity in Commerce 115
Distribution Nationwide Distribution.
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.