CIVCO Biopsy Starter Kit — Class II medical device recall Z-0288-2016
Terminated recall by Civco Medical Instruments Co. Inc., reported 2015-11-25, distributed nationwide. Sterility of the product cannot be assured.
| Recall number | Z-0288-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Co. Inc., Kalona, IA, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CN, CZ, DE, DK, EC, ES, FI, FR, GB, HK, IL, IN, IT, JP, KR, KW, NL, NO, NZ, PL, QA, RO, SA, SG, TR, TT, TW, UA, ZA |
| Quantity | 1,139 boxes |
| Reason classes | sterility |
| Model numbers | 10787043, 11001906 |
Product
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Reason for recall
Sterility of the product cannot be assured.
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-0288-2016. 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.