Z-0562-2019 Class II Terminated
FDA device recall Z-0562-2019 was initiated by CIVCO Medical Instruments Co., Inc. on November 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 November 20, 2020). Affected quantity: 738 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- November 2, 2018
- Termination Date
- November 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 738 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.