MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PA

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 Numbers DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488; b) Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563; c) Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320; d) Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422; e) Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339; f) Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352; g) Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619; h) Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634; i) Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639; j) Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492; k) Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209; l) Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539; m) Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173; n) Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553; o) Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878; p) Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852; q) Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318; r) Mode

UPC codes

10195327339487, 40195327339488, 10889942688562, 40889942688563, 10889942760329, 40889942760320, 10889942714421, 40889942714422, 10195327152338, 40195327152339, 10195327021351, 40195327021352, 10193489202618, 40193489202619, 10193489289633, 40193489289634, 10889942976638, 40889942976639, 10195327046491, 40195327046492, 10195327248208, 40195327248209, 10195327116538, 40195327116539, 10193489951172, 40193489951173, 10889942621552, 40889942621553, 10195327093877, 40195327093878, 10195327211851, 40195327211852, 10193489466317, 40193489466318, 10193489594119, 40193489594110, 10195327045678, 40195327045679, 10889942693450, 40889942693451

Source

Official record: FDA (Device enforcement) ↗

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