MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2183-2023)
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) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
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 DYNDV2407A, UDI/DI (EA) 10193489817010UDI/DI (CS) 40193489817011; b) Model Number DYNDV2435, UDI/DI (EA) 10195327043667UDI/DI (CS) 40195327043668; c) Model Number DYNDV2518, UDI/DI (EA) 10195327089078UDI/DI (CS) 40195327089079; d) Model Number DYNJ64871, UDI/DI (EA) 10193489225365UDI/DI (CS) 40193489225366
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Voluntary: Firm initiated