CLASS II Device recall · Reported 1 Mar 2017 · FDA Enforcement Report
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/ Trocar recalled
Degania Silicone is recalling Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/ Trocar, distributed in Puerto Rico. The recall was initiated on 31 Jan 2017 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-1233-2017
- FDA event ID
- 76368
- Recalling firm
- Degania Silicone, Dganya Bet, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jan 2017
- FDA classified
- 22 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 31 Jan 2017 | Recall initiated by company | |
| 22 Feb 2017 | Classified by FDA | +22 days |
| 1 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product sterility compromised due to breach of sterile barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Where it was distributed
To PR only
Questions about this recall
Why was it recalled?
Product sterility compromised due to breach of sterile barrier
Which lots are affected?
Lot Number: P1546816 Expiration date: January 2021
Where was it sold?
To PR only
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Temperature Abuse | 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 |
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