Device recall

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

FDA recall source

Recall number

Z-3137-2026

Event id

99583

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Sep 23, 2026

Posted

Sep 11, 2026

Initiated

Jul 23, 2026

Center classification date

Sep 10, 2026

Product code

LRO

Device type

General Surgery Tray

Reason

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.

Root cause

Packaging process control

Quantity

135 units

Code info

UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372

Distribution

US Nationwide distribution in the state of CA.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K213481

Location

Northfield, IL, United States