Recall Z-0562-2019 ยท ITX Transducer, Ultrasonic, Diagnostic
CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
| Date | Nov 2, 2018 |
| Status | Terminated |
| Reason | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. |
| 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 | 738 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 |