Z-1748-2014Class II

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

Name: Z-1748-2014 Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc
Creator: Sakura Finetek USA Inc
Published: 2014-04-16
License: https://open.fda.gov/license/

Sakura Finetek USA Inc / initiated 2014-04-16 / Terminated / root cause: packaging

FDA source

Sakura Finetek USA Inc began a recall of Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc on 2014-04-16. FDA classified it as Class II and gives the reason as "This Lot has variations in melting temperature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1748-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-06-10
Terminated: 2014-09-02
Recalling firm: Sakura Finetek USA Inc
Product: Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
Product code: KEO Formulations, Paraffin, All
Reason for recall: This Lot has variations in melting temperature.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Product Code: 7052. Lot Number: 263922.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1748-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10

Product code KEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)