Device product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
Z-2198-2023
Product summary
- Event
- Event 92466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 575 units
- Official record key
device-enforcement:Z-2198-2023
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 DYNDH1112, UDI/DI (EA) 10889942277360, UDI/DI (CS) 40889942277361; b) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; c) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836
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.