Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH C
Summary
The FDA issued a Class II for Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART by Medline Industries, LP. Reason: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) prox.
Details
Source
Device Recall
External ID
Z-2611-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
Lot/Code Info: DYNJ909090B UDI-DI 10195327652432 Lots 24EBL051 24GBG271 CDS982523M UDI-DI 10195327560591 Lots 24ALA227 24BLA369 24CLA108 24CLA518 24DLA082 24ELB053 24ILA112
Quantity Affected: 9,272 kits
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.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-28
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2611-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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