Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN J...

FDA Device Recall #Z-2265-2019 — Class II — June 28, 2019

Recall Summary

Recall Number Z-2265-2019
Classification Class II — Moderate risk
Date Initiated June 28, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Degania Silicone, Ltd.
Location Dganya Bet, N/A
Product Type Devices
Quantity 2160

Product Description

Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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

Lot / Code Information

Lot Codes: P1851056 P1867059

Other Recalls from Degania Silicone, Ltd.

Recall # Classification Product Date
Z-0809-2020 Class II Medline Thermistor Foley Catheter 14 FR 5-10 ml... Dec 2, 2019
Z-2260-2019 Class II Cardinal Health Jackson-Pratt Channel Drain 15... Jun 28, 2019
Z-2267-2019 Class II Smith & Nephew Negative Pressure Wound Therapy ... Jun 28, 2019
Z-2262-2019 Class II Cardinal Health Jackson-Pratt Channel Drain 15F... Jun 28, 2019
Z-2264-2019 Class II Cardinal Health Jackson-Pratt Channel Drain 19F... Jun 28, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.