CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
Cardinal Health Jackson-Pratt Channel Drain, 3/4 flutes recalled
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drain, 3/4 flutes, with trocar Cardinal Health: PN, distributed nationwide in the US. The recall was initiated on 28 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2265-2019
- FDA event ID
- 83287
- Recalling firm
- Degania Silicone, Dganya Bet, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jun 2019
- FDA classified
- 12 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 28 Jun 2019 | Recall initiated by company | |
| 12 Aug 2019 | Classified by FDA | +45 days |
| 21 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Codes: P1851056 P1867059
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 83287This product is part of a recall event; the main page for the event is Cardinal Health Jackson-Pratt Channel Drain, Full flutes recalled.
More recalls from Degania Silicone
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Thermistor Foley Catheter 5-, non sterile recalled | Degania Silicone | Sterility | IL |
| Device | CLASS II | Medline Silicone Drain 3/16" Full Fluted PN recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain, Full flutes recalled | Degania Silicone | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |