Z-2262-2019 Class II Terminated
FDA device recall Z-2262-2019 was initiated by Degania Silicone, Ltd. on Jun 28, 2019 and is designated Class II. 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… The recall status is terminated (terminated Oct 22, 2020). Affected quantity: 6080.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2019
- Initiation Date
- Jun 28, 2019
- Termination Date
- Oct 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6080
Product Description
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 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
Distribution Pattern
Nationwide Distribution
Code Information
Lot Codes: P1841752 P1852268 P1845823
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2262-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026