Date Initiated by Firm |
April 16, 2014 |
Date Posted |
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
|
Product |
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc. |
Code Information |
Product Code: 7052. Lot Number: 263922. |
Recalling Firm/ Manufacturer |
Sakura Finetek USA Inc 1750 W 214th St Torrance CA 90501-2857
|
For Additional Information Contact |
310-972-7800
|
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
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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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