← FDA ENFORCEMENT
Z-2607-2026Class II

Medline Industries, LP

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 & CAPA
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.

Product description

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N

Code / lot info

DYNJ901328G UDI-DI 10198459601538 Lots 26ABD786 26CBD768 26DBJ434 DYNJ903465K UDI-DI 10198459292743 Lots 25GDB257 26ADA464 26BDA587 26DDA021 DYNJ909090G UDI-DI 10198459406027 Lots 25LBH690 25LBP697 DYNJ906102M UDI-DI 10198459406409 Lots 25JBE315 25KBI700 25KBM827 25LBB028 26ABH106 26CBQ206 DYNJ902664M UDI-DI 10198459349126 Lots 25ILA177 25KLA500 DYNJ902664N UDI-DI 10198459675287 Lot 26BLA783

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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.