MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2187-2023)
See the recall detail below. You can also see other recalls from the same firm in 2023.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FETAL INTERVENTION, Model Number DYNJ66041A; f) FETAL INTERVENTION, Model Number DYNJ66041B
Class II
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDV2200, UDI/DI (EA) 10888277742550, UDI/DI (CS) 40888277742551; b) Model Number DYNDV2397, UDI/DI (EA) 10193489388466, UDI/DI (CS) 40193489388467; c) Model Number DYNJ24276C, UDI/DI (EA) 10884389431184, UDI/DI (CS) 40884389431185; d) Model Number DYNJ66041, UDI/DI (EA) 10193489315820, UDI/DI (CS) 40193489315821; e) Model Number DYNJ66041A, UDI/DI (EA) 10193489480283, UDI/DI (CS) 40193489480284; f) Model Number DYNJ66041B, UDI/DI (EA) 10195327151072, UDI/DI (CS) 40195327151073;
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Voluntary: Firm initiated