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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 Recall
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Date Posted June 10, 2014
Recall Status1 Terminated on September 02, 2014
Recall Number Z-1748-2014
Recall Event ID 68081
Product Classification Formulations, Paraffin, All - Product Code KEO
Product Tissue-Tek® PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg.
Code Information Product Code: 7052. Lot Number: 263922.
Recalling Firm/
Sakura Finetek USA Inc
1750 W 214th St
Torrance, California 90501-2857
Manufacturer Reason
for Recall
Sakura Finetek USA, Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin (Product Code 7052), Lot Number 263922 because it was identified that Lot 263922 has variations in melting temperature.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.