Z-0566-2019 Class II Terminated
FDA device recall Z-0566-2019 was initiated by CIVCO Medical Instruments Co., Inc. on November 2, 2018 and is designated Class II. The recall status is terminated (terminated November 20, 2020). Affected quantity: 297 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
- 297 boxes
Product Description
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
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
Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.