Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Reason for recall: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. Quantity: # included in 3,740,814 units total Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339; b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541; c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216; d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209; e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515; f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559; g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476; h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184; i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359; j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177; k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027; l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506; m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037; n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449; o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675; p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934; q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509;
10653160354338, 40653160354339, 10889942428540, 40889942428541, 10888277739215, 40888277739216, 10888277739208, 40888277739209, 10193489674514, 40193489674515, 10193489854558, 40193489854559, 10653160309475, 40653160309476, 10193489953183, 40193489953184, 10193489564358, 40193489564359, 10889942843176, 40889942843177, 10193489533026, 40193489533027, 10889942708505, 40889942708506, 10888277734036, 40888277734037, 10193489836448, 40193489836449, 10888277295674, 40888277295675, 10889942446933, 40889942446934, 10889942611508, 40889942611509, 10889942519835, 40889942519836, 10889942742233, 40889942742234, 10889942795475, 40889942795476
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.