Device product
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
Z-2187-2023
Product summary
- Event
- Event 92466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8974 units
- Official record key
device-enforcement:Z-2187-2023
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 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;
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.