Medline Industries Recalls Medline Kits: 1) CATH LAB CDS
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Medline Industries Recalls Medline Kits: 1) CATH LAB CDS
Medline Industries, LP · Class II — Moderate Risk

Product Description
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82
Reason for Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database