Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Firm state
IL
Product quantity
9,272 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason 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.
Product description
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Code / lot info
UDI-DI 10195327033620 Lots 21KBN891 21KBO410 22ABA676 22ABY937 22BBN909 22BBT447 23ABO303
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.