Class II — Civco Medical Instruments Co. Inc.
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Registered facility | CIVCO Medical Instruments Co., Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A cover failed leak testing during validation testing of new needle guides from a replacement tool. |
| Product | CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. |
| Quantity | 177 boxes |
| Distribution | Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada |
| Initiated | 2018-02-23 |
| Classified | 2018-08-22 |
| Terminated | 2020-10-06 |
| Recall number | Z-2888-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Civco Medical Instruments Co. Inc. (Z-2888-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80704/
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