Z-1738-2024Class II

Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601

Name: Z-1738-2024 Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Creator: Cardinal Health 200, LLC
Published: 2024-03-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-03-27 / Open, Classified / root cause: sterility

FDA source

Cardinal Health 200, LLC began a recall of Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601 on 2024-03-27. FDA classified it as Class II and gives the reason as "Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1738-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-27
Posted: 2024-05-01
Recalling firm: Medtronic, Inc.
Product: Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Product code: GBX Catheter, Irrigation
Reason for recall: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 03/27/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the following: Locate, segregate, and cease use of the affected product, disseminate the notice to those who handle the product. Distributors were directed to notify their customers. CONTACT the appropriate Customer Service group to arrange return of product and with questions related to this notification. 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: 64 cases of 6
Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
Product codes and lots: UDI/DI 50192253016459 (Case), 10192253016451 (Each), Lot Numbers: 210751D6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1735-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01
Z-1736-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01
Z-1737-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01
Z-1738-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01
Z-1739-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)