FDA Device recall Z-0899-2018
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile
- FDA Device
- Class III
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class III recall of Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile by Degania Silicone, citing sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0899-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-10-03 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Degania Silicone |
| Distribution | PR |
Product
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Reason
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Identifiers
| code_info | Lot No P1607442. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0899-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.