Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;
Hazard / Issue
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892; b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864; c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939; d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526; e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310; f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088; g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421; h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659; i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983; j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679; k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249; l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458; m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542; n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805; o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823; p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412; q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429; r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060; s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957; t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233; u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777; v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667; w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338; x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145; y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628; z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337; aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184; bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238; cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115; dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845; ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494; ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811; gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555; hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562