Recall Z-2888-2018 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Co. Inc.
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | A cover failed leak testing during validation testing of new needle guides from a replacement tool. |
| Root cause | Device Design |
| Action | Telephone Script to be read: CIVCO is calling to notify our customers regarding a recall action being initiated. CIVCO has recently discovered a dimensional issue in our Infiniti bracket which may allow the needle guide to a puncture a cover. You are being notified, as your facility has been identified as having received product from one of the affected manufacturing lots. Advise on Action to be taken by Customer or Distributor: To return Infiniti needle guide, contact your Account Representative at 800-445-6741 or 319-248-6757. Alternately you may also use email at order@civco.com to sched |
| Quantity | 177 boxes |
| Distribution | Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM Civco Medical Instruments, Jan 19, 2010 |