MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ5595

Hazard

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Details from the source

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 DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685; b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230; c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673; d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828; e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677; f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406; g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678; h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470; i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181; j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604; k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647; l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840; m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219; n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700; o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165; p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648; q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835

UPC codes

10888277757684, 40888277757685, 10193489214239, 40193489214230, 10193489547672, 40193489547673, 10193489569827, 40193489569828, 10889942640676, 40889942640677, 10195327261405, 40195327261406, 10195327323677, 40195327323678, 10193489443479, 40193489443470, 10193489813180, 40193489813181, 10889942721603, 40889942721604, 10193489360646, 40193489360647, 10889942747849, 40889942747840, 10889942963218, 40889942963219, 10888277779709, 40888277779700, 10889942819164, 40889942819165, 10889942828647, 40889942828648, 10889942835492, 40889942835493, 10889942843732, 40889942843733, 10889942851836, 40889942851837, 10193489809213, 40193489809214

Source

Official record: FDA (Device enforcement) ↗

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