Class II — RanD S.r.l.
| Recalling firm | RAND S.p.A. |
|---|---|
| Registered facility | RAND S.p.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter. |
| Quantity | 40 |
| Distribution | The products were distributed to the following US states: FL, IL, TN, WI |
| Initiated | 2021-04-30 |
| Classified | 2021-07-09 |
| Terminated | 2024-02-05 |
| Recall number | Z-2049-2021 |
| 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 — RanD S.r.l. (Z-2049-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87926/
Alerts for RAND S.p.A.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.