CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
FDA Recall Z-0562-2019 · Posted None
Recalling FirmCIVCO Medical Instruments Co., Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2018-11-02
Date Terminated2020-11-20
Product Quantity738 boxes
Reason for Recall
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Firm Action
The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.