Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAG

Hazard

Unapproved design changes to the products outside of the 510(k) clearance.

Details from the source

Reason for recall: Unapproved design changes to the products outside of the 510(k) clearance. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados. Quantity: 270,311 total Lot/code info: DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248 23EBK921 23FBS130 23HBB516 23IBS065 23JBP123 23LBP196 24ABR004 24ABR121 24BBG855 24GBV377 24JBI914 24KBD153 24LBB665 DYNJ35615G UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT 23EBR748 DYNJ0842516G UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS 24CDB991 24GDB891 24IDA796 24KDB683 DYNJ61926 UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS 23CBK311 23DBM226 23FBP893 23GBN159 23HBC859 23JBH552 23LBV456 24DBM081 24EBS504 24FBR479 DYNJ47645C UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS 23IMH312 23LMD467 24BMB620 24DMD512 24FMF757 24GMD538 24JMC369 24KMB831 24LMD945 DYNJ47782G UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT 24GMA622 DYNJT2201S UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT 23HMG629 DYNJ33415A UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT 24CBG963 DYNJ64877B UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS 23CBF259 23HBM117 23HBO973 23KBD360 23LBG859 24ABB266 24CMJ034 24FMD963 24HMH185 24JMD105 DYNJ65925D UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT 24DLA029 DYNJ44100M UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS 23IMG347 23JMI669 23LME170 24AMI085 24CMA877 24CMJ446 24DME309 24FMC387 24FMC900 24FMF012 24FMH007 24GMC363 24HMF632 24J

UPC codes

10198459335266, 40198459335267, 10195327393090, 40195327393091, 10195327674168, 40195327674169, 10193489616750, 40193489616751, 10195327099404, 40195327099405, 10195327286392, 40195327286393, 10193489610406, 40193489610407, 10195327355173, 40195327355174, 10195327495640, 40195327495641, 10195327263003, 40195327263004, 10888277792555, 40888277792556, 10193489415896, 40193489415897, 10195327531188, 40195327531189, 10195327324988, 40195327324989, 10195327271640, 40195327271641, 10193489968170, 40193489968171, 10195327525040, 40195327525041, 10195327351335, 40195327351336, 10198459128622, 40198459128623, 10195327347451, 40195327347452

Source

Official record: FDA (Device enforcement) ↗

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