Ch24 round silicone catheter — Class II medical device recall Z-2049-2021
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-2049-2021 |
|---|---|
| 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 | 40 |
| Reason classes | sterility |
| Lot numbers | F180264 |
Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
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-2049-2021. 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.