FDA Device recall Z-2049-2021
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099
- FDA Device
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099 by Rand S R L, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2049-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-30 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Rand S R L |
| Distribution | FL, IL, TN, WI |
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
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.
Identifiers
| code_info | Lot Numbers: F180264 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2049-2021%22
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