Device product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
Z-2176-2023
Product summary
- Event
- Event 92466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4644 units
- Official record key
device-enforcement:Z-2176-2023
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 DYNJ46967F, UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048; b) Model Number DYNJ62557, UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153; c) Model Number DYNJ81973, UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878; d) Model Number TVS4000K, UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863;
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.