Device product
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Z-0564-2019
Product summary
- Event
- Event 81361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 948 boxes
- Official record key
device-enforcement:Z-0564-2019
Official wording
Reason: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
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.
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.
Derived failure modes
-
Unknown
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.