Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ07740

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: DYNJ0429339L UDI-DI 10195327586508 (EA) 40195327586509 (CS) LOTS 24BMG223 24DMG627 DYNJ0429339M UDI-DI 10198459021541 (EA) 40198459021542 (CS) LOTS 24GMH043 24HMK218 DYNJ0774026K UDI-DI 10198459053115 (EA) 40198459053116 (CS) LOTS 24FBR752 24GBE275 24HBJ727 24IBD206 24KBB390 24KBT291 DYNJ83746B UDI-DI 10198459077760 (EA) 40198459077761 (CS) LOTS 24HBB576 24JBF419 24LBG659 DYNJ85557A UDI-DI 10195327657901 (EA) 40195327657902 (CS) LOT 24HBT042 DYNJ17218S UDI-DI 10195327617547 (EA) 40195327617548 (CS) LOTS 24ADC205 24DDA061 DYNJ17218T UDI-DI 10198459014956 (EA) 40198459014957 (CS) LOTS 24FDA217 24GDB466 24IDB458 DYNJ0842499L UDI-DI 10198459119248 (EA) 40198459119249 (CS) LOT 24LDB079 DYNJ0842478M UDI-DI 10198459119255 (EA) 40198459119256 (CS) LOT 24LDB078 DYNJ21259O UDI-DI 10195327666323 (EA) 40195327666324 (CS) LOTS 24EBQ265 24EBQ331 24KBG416 24LBP987 DYNJ68653D UDI-DI 10198459123122 (EA) 40198459123123 (CS) LOTS 24IBI799 24JBJ553 24KBT807 24LBQ652 DYNJ50779G UDI-DI 10195327686499 (EA) 40195327686490 (CS) LOTS 24GMA788 24HMA312 24IMI472 24KMC197 DYNJ51423G UDI-DI 10198459022395 (EA) 40198459022396 (CS) LOTS 24FLA167 24HLA548 24HLA720 24JLA538 DYNJ0101292I UDI-DI 10198459119064 (EA) 40198459119065 (CS) LOTS 24JDA749 24KDB872 24LDA883 DYNJ0842793I UDI-DI 10198459119095 (EA) 40198459119096 (CS) LOTS 24IDA565 24JDB658 DYNJ87263 UDI-DI 10198459026263 (EA) 40198459026264 (CS) LOTS 24GMF532 24KME090 DYNJ0842873L UDI-DI 10198459119163 (EA) 40198459119164 (CS) LOTS 24JDB216 24KMI624 DYN

UPC codes

10195327586508, 40195327586509, 10198459021541, 40198459021542, 10198459053115, 40198459053116, 10198459077760, 40198459077761, 10195327657901, 40195327657902, 10195327617547, 40195327617548, 10198459014956, 40198459014957, 10198459119248, 40198459119249, 10198459119255, 40198459119256, 10195327666323, 40195327666324, 10198459123122, 40198459123123, 10195327686499, 40195327686490, 10198459022395, 40198459022396, 10198459119064, 40198459119065, 10198459119095, 40198459119096, 10198459026263, 40198459026264, 10198459119163, 40198459119164, 10198459072499, 40198459072490, 10198459018800, 40198459018801, 10198459099755, 40198459099756

Source

Official record: FDA (Device enforcement) ↗

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