Z-0564-2019 Class II Terminated
FDA device recall Z-0564-2019 was initiated by CIVCO Medical Instruments Co., Inc. on Nov 2, 2018 and is designated Class II. Reason for recall: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. The recall status is terminated (terminated Nov 20, 2020). Affected quantity: 948 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2018
- Initiation Date
- Nov 2, 2018
- Termination Date
- Nov 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 948 boxes
Product Description
Reason for Recall
Distribution Pattern
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, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0564-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026