Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Summary
The FDA issued a Class II for Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N by Medline Industries, LP. Reason: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product c.
Details
Source
Device Recall
External ID
Z-3137-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Lot/Code Info: UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
Quantity Affected: 135 units
Reason for Recall
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
Distribution
US Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-23
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 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 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 577 FDA actions in our database, including 553 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3137-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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