Cardinal Health Jackson-Pratt Channel Drain 19FR — Class II medical device recall Z-2264-2019
Terminated recall by Degania Silicone, Ltd., reported 2019-08-21, distributed nationwide. 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection poin
| Recall number | Z-2264-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degania Silicone, Ltd., Dganya Bet, N/A, Israel |
| Recall initiated | 2019-06-28 |
| Classified | 2019-08-12 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 6,960 |
| Reason classes | device malfunction |
| Lot numbers | P1861538, P1865416, P1903570 |
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
Reason for recall
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
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-2264-2019. 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.