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Terminated

CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.

FDA Recall Z-0576-2019 · Posted None

Recalling FirmCIVCO Medical Instruments Co., Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2018-11-02
Date Terminated2020-11-20
Product Quantity135 boxes

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.

K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYSonosite,Inc. · 2003-01-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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