Device product
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
Z-2183-2023
Product summary
- Event
- Event 92466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35717 units
- Official record key
device-enforcement:Z-2183-2023
Official wording
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Code information: 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
Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Derived failure modes
-
Unknown
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.