Recall Z-1748-2014 ยท KEO Formulations, Paraffin, All
Sakura Finetek USA Inc
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
| Date | Jun 10, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | This Lot has variations in melting temperature. |
| 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 | 115 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.