Recall Z-0576-2019 ยท ITX Transducer, Ultrasonic, Diagnostic
CIVCO Medical Instruments Co., Inc.
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
| Date | Nov 2, 2018 |
| Status | Terminated |
| Reason | |
| Root cause | Other |
| Action | The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory. |
| Quantity | 135 boxes |
| Distribution | Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Rom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY Sonosite,Inc., Jan 22, 2003 |