Recall Z-0569-2019 ยท ITX Transducer, Ultrasonic, Diagnostic
CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
| 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 | 234 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 |