Recall Z-1748-2014
Sakura Finetek USA Inc · initiated April 16, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
Codes / lots: Product Code: 7052. Lot Number: 263922.
Reason for recall
This Lot has variations in melting temperature.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1748-2014
- Initiated
- April 16, 2014
- Posted by FDA
- June 10, 2014
- Terminated
- September 2, 2014
- Product code
- KEO – Formulations, Paraffin, All
- Quantity
- 115
- Distribution
- Nationwide Distribution.
- Recalling firm
- Sakura Finetek USA Inc, Torrance, CA