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Recall Observatory FDA recall evidence

Device product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;

Z-2196-2023

May 18, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92466
Status
Ongoing
Classification
Class II
Quantity
2420 units
Official record key
device-enforcement:Z-2196-2023

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 DYNJ44410G. UDI/DI (EA)10193489958447, UDI/DI (CS)40193489958448; b) Model Number DYNJ9048708I. UDI/DI (EA)10195327072735, UDI/DI (CS)40195327072736; c) Model Number PHS762887001B. UDI/DI (EA)10889942849314, UDI/DI (CS) 40889942849315; d) Model Number TVS4700. UDI/DI (EA)10816982023398, UDI/DI (CS)40816982023399;

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

    reason.no_named_rule · v1.0.0

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.