Silicone Fluted Round Drain 24Fr — Class III medical device recall Z-0899-2018
Terminated recall by Degania Silicone, Ltd., reported 2018-03-14, distributed in PR. Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to
| Recall number | Z-0899-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degania Silicone, Ltd., Dganya Bet, N/A, Israel |
| Recall initiated | 2017-10-03 |
| Classified | 2018-03-05 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2020-10-21 |
| Distributed | PR |
| Quantity | 4,000 units |
| Reason classes | labeling, sterility |
| Lot numbers | P1607442 |
| Model numbers | JP-2234 |
Product
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Reason for recall
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
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-0899-2018. 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.