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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Tissue-TekĀ® PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg.
Recall Number Z-1748-2014
Classification Class II
Code Info Product Code: 7052. Lot Number: 263922.
Product Distributed Qty 115
Reason For Recall Sakura Finetek USA, Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin because it was identified that the affected lot has variations in melting temperature.

Event Detail

Event Id 68081
Product Type Devices
Status Ongoing
Recalling Firm Sakura Finetek USA Inc
City Torrance
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.