Hang&Go — Class II medical device recall Z-2048-2021
Terminated recall by RanD S.r.l., reported 2021-07-21, distributed in FL, IL, TN, WI. The sterilization contractor informed the company of a quality issue possibly affecting the sterilization proc
| Recall number | Z-2048-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RanD S.r.l., Medolla, Italy |
| Recall initiated | 2021-04-30 |
| Classified | 2021-07-09 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2024-02-05 |
| Distributed | FL, IL, TN, WI |
| Quantity | 72 |
| Reason classes | sterility |
| Lot numbers | F180266, F180315, F190169 |
Product
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Reason for recall
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
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-2048-2021. 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.