Recall Z-2611-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-05-28. It names one FDA 510(k) clearance: K213481. Product: Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M. Reason: 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-28
- Firm location
- Northfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.