Z-2611-2026 Class II Ongoing
FDA device recall Z-2611-2026 was initiated by Medline Industries, LP on May 28, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 9,272 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 28, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,272 kits
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Code Information
DYNJ909090B UDI-DI 10195327652432 Lots 24EBL051 24GBG271 CDS982523M UDI-DI 10195327560591 Lots 24ALA227 24BLA369 24CLA108 24CLA518 24DLA082 24ELB053 24ILA112