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Terminated

Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

FDA Recall Z-1748-2014 · Posted 2014-06-10

Recalling FirmSakura Finetek USA Inc
Recall StatusTerminated
Product CodeKEO
Date Initiated2014-04-16
Date Terminated2014-09-02
Product Quantity115

Reason for Recall

This Lot has variations in melting temperature.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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