MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model

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: 19940 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS982889I, UDI/DI (EA) 10889942208067, UDI/DI (CS) 40889942208068; b) Model Number DYNDH1722, UDI/DI (EA) 10195327132163, UDI/DI (CS) 40195327132164; c) Model Number DYNJ0604434X, UDI/DI (EA) 10889942763801, UDI/DI (CS) 40889942763802; d) Model Number DYNJ44322I, UDI/DI (EA) 10193489530612, UDI/DI (CS) 40193489530613; e) Model Number DYNJ44348D, UDI/DI (EA) 10889942646722, UDI/DI (CS) 40889942646723; f) Model Number DYNJ44348F, UDI/DI (EA) 10193489530650, UDI/DI (CS) 40193489530651; g) Model Number DYNJ50712C, UDI/DI (EA) 10193489870169, UDI/DI (CS) 40193489870160; h) Model Number DYNJ56907D, UDI/DI (EA) 10193489831566, UDI/DI (CS) 40193489831567; i) Model Number DYNJ58127B, UDI/DI (EA) 10193489482799, UDI/DI (CS) 40193489482790; j) Model Number DYNJ61749A, UDI/DI (EA) 10195327063016, UDI/DI (CS) 40195327063017; k) Model Number DYNJ63149A, UDI/DI (EA) 10193489786477, UDI/DI (CS) 40193489786478; l) Model Number DYNJ65963A, UDI/DI (EA) 10193489992052, UDI/DI (CS) 40193489992053; m) Model Number DYNJ66402, UDI/DI (EA) 10193489352016, UDI/DI (CS) 40193489352017; n) Model Number DYNJ66402A, UDI/DI (EA) 10193489840520, UDI/DI (CS) 40193489840521; o) Model Number DYNJ66402C, UDI/DI (EA) 10193489938456, UDI/DI (CS) 40193489938457; p) Model Number DYNJ66404, UDI/DI (EA) 10193489352078, UDI/DI (CS) 40193489352079; q) Model Number DYNJ66404A, UDI/DI (EA) 10193489840537, UDI/DI (CS) 401934

UPC codes

10889942208067, 40889942208068, 10195327132163, 40195327132164, 10889942763801, 40889942763802, 10193489530612, 40193489530613, 10889942646722, 40889942646723, 10193489530650, 40193489530651, 10193489870169, 40193489870160, 10193489831566, 40193489831567, 10193489482799, 40193489482790, 10195327063016, 40195327063017, 10193489786477, 40193489786478, 10193489992052, 40193489992053, 10193489352016, 40193489352017, 10193489840520, 40193489840521, 10193489938456, 40193489938457, 10193489352078, 40193489352079, 10193489840537, 40193489840538, 10193489941166, 40193489941167, 10193489874655, 40193489874656, 10193489929461, 40193489929462

Source

Official record: FDA (Device enforcement) ↗

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