Medline Industries, LP: Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465

Hazard

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.

Details from the source

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: US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI. Quantity: 9,272 kits Lot/code info: CDS982269K UDI-DI 10193489906844 Lots 21HBN691 21JBQ518 21LBD444 CDS982269L UDI-DI 10195327018016 Lots 21LBP501 22ABR514 22BBE936 22FBV989 CDS982269M UDI-DI 10195327192808 Lots 22JBE028 22LBF124 23ABP909 23CBO580 CDS982269N UDI-DI 10195327352998 Lots 23GBC969 23HBS959 23KBW067 23LBF510 24CBO691 24DBR250 24EBU619 24GBF288 25ABM339 25CBJ666 25HBH657 25IBM477 26BBG451 DYNJ901328D UDI-DI 10193489854923 Lots 21CBQ397 21FBJ935 21HBR220 21JBV897 21JBV898 22ABG611 DYNJ901328F UDI-DI 10195327044572 Lots 22CBX749 22FBX103 23ABC195 23EBG860 23EBL637 23EBS968 23FBM688 23GBS043 24EBL355 24FBJ301 24IBS567 24JBD767 24JBU518 24KBL806 24LBF815 25DBF590 25FBQ740 25GBH267 25JBQ634 DYNJ903465F UDI-DI 10193489918397 Lots 21FDB453 21HDB016 21IDB927 21KDA273 21LDA283 21LDB750 22CDA262 DYNJ903465G UDI-DI 10195327175559 Lots 22FDA593 22IDA677 22KDA077 23ADB246 DYNJ907857 UDI-DI 10193489909364 Lots 21GBJ159 21IBX945 21LBJ320 22ABH627 DYNJ907857A UDI-DI 10195327133160 Lots 22HBK592 22KBM436 DYNJ907857B UDI-DI 10195327256869 Lots 22KBN208 23ABM669 23IBE277 DYNJ905857A UDI-DI 10193489946680 Lots 22CBW896 22DBR508 22GBG113 22GBW887 22IBU528 22JBA758 22KBJ132 23ABP277 23ABP278 23ABS778 23DBD840 23EBJ932 23EBR134 23FBM591 23FBS624 23HBU190 24FBG082 24GBE581 24HBM636 24IBS825 24JBV903 24KBU708 24LBU110 25BBG391 25CBJ747 25DBP832 CDS981161AA UDI-DI 10193489303407 Lots 21DBH590 21DBU485 CDS981161AB UDI-DI 10193489817461 Lots 21DBT869 21FBD406 21FBK899 21HBT158 21IBJ277 21IBW875 22BBA363 22DBH285 22DBT988 22HBO

UPC codes

10193489906844, 10195327018016, 10195327192808, 10195327352998, 10193489854923, 10195327044572, 10193489918397, 10195327175559, 10193489909364, 10195327133160, 10195327256869, 10193489946680, 10193489303407, 10193489817461, 10193489571905, 10195327268350, 10198459084768, 10193489481730, 10193489904659, 10193489263046, 10193489278231, 10195327228316, 10195327650148, 10193489818710, 10193489427141, 10193489843729, 10193489372199, 10195327111151, 10198459094187, 10193489999082, 10195327222574, 10195327275419, 10195327326869, 10195327412234, 10198459055355, 10195327560485, 10198459079733, 10198459242564, 10195327368876, 10195327511142

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.