Device product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Z-2192-2023
Product summary
- Event
- Event 92466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180 units
- Official record key
device-enforcement:Z-2192-2023
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: Model Number DYNJ44322G, UDI/DI (EA) 10889942646661, UDI/DI (CS) 40889942646662
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.