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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B

Z-2606-2026

May 28, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 99209
Status
Ongoing
Classification
Class II
Quantity
9,272 kits
Official record key
device-enforcement:Z-2606-2026

Official wording

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.

Code information: UDI-DI 10195327345044 Lots 23DBI807 23FBG708 23GBK642 23KBO477 24BBG198 24FBN889 24GBJ879 24HBR045 24LBT492 25ABL957 25BBN572 25GBT734 25HBQ817 25LBM617 26BBK766 26DBE720

Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.