CIVCO Needle Guide Starter Kit — Class II medical device recall Z-0569-2019
Terminated recall by CIVCO Medical Instruments Co., Inc., reported 2018-12-19.
| Recall number | Z-0569-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIVCO Medical Instruments Co., Inc., Coralville, IA, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-11-20 |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, DE, DK, EE, ES, FR, GB, HK, HR, IL, IN, IT, JP, LB, LT, LV, NL, NZ, PH, PL, PT, QA, RO, SA, SG, TR, TT, TW, UA, ZA |
| Quantity | 234 boxes |
| Model numbers | P12922-01, P12922-02 |
Product
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
Reason for recall
Not stated by FDA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0569-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.