Device product
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
Z-2606-2026
Product summary
- 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
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.