CLASS II ONGOING Device recall · Reported 25 Jan 2023 · FDA Enforcement Report
Cardinal Health Jackson-Pratt Channel Drain recalled
Cardinal Health 200 is recalling Cardinal Health Jackson-Pratt Channel Drain, distributed nationwide in the US. The recall was initiated on 14 Dec 2022 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-0989-2023
- FDA event ID
- 91322
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Dec 2022
- FDA classified
- 18 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Dec 2022 | Recall initiated by company | |
| 18 Jan 2023 | Classified by FDA | +35 days |
| 25 Jan 2023 | 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
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
Product as listed by the FDA
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
Questions about this recall
Is Cardinal Health Jackson-Pratt Channel Drain recalled?
Yes. Cardinal Health 200 recalled Cardinal Health Jackson-Pratt Channel Drain on 14 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0989-2023.
Why was it recalled?
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
Which lots are affected?
UDI/DI 50885380182639(cs), 20885380182638(ea), Lot Numbers: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, N220163
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
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.
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