Z-2612-2026Class II

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A

Name: Z-2612-2026 Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Creator: Medline Industries, LP
Published: 2026-05-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-28 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A on 2026-05-28. FDA classified it as Class II and gives the reason as "Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2612-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-28
Posted: 2026-06-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Product code: OES Cardiac Catheterization Kit
Reason for recall: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
FDA root cause: Process change control
Action: On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 9,272 kits
Distribution: US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Product codes and lots: UDI-DI 10195327033620 Lots 21KBN891 21KBO410 22ABA676 22ABY937 22BBN909 22BBT447 23ABO303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2612-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2606-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2607-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2608-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2609-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2610-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2611-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2612-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26
Z-2613-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26

Product code OES

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)