Z-0971-2023Class II

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190

Name: Z-0971-2023 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Creator: Cardinal Health 200, LLC
Published: 2022-12-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-12-14 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 on 2022-12-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0971-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-14
Posted: 2023-01-18
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Product code: GBX Catheter, Irrigation
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.
FDA root cause: Unknown/Undetermined by firm
Action: Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown above. 2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether you have affected product. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: . Hospital 800-964-5227 . Federal Government 800-444-1166 . Distributor 800-635-6021 . All other customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 3507
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
Product codes and lots: UDI/DI 50885380182455(cs), 20885380182454(ea), Lot Numbers: N210278, N210347, N210368, N210423, N210460, N210468 , N210469, N210543, N220099, N220050, N220139, N220163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0968-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0969-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0970-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0971-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0972-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0973-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0974-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0975-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0976-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0977-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0978-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0979-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0980-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0981-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0982-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0983-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0984-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0985-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0986-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0987-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0988-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0989-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0990-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0991-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0992-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0993-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18
Z-0994-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-18

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)