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Recall Observatory FDA recall evidence

Device product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A

Z-2182-2023

May 18, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92466
Status
Ongoing
Classification
Class II
Quantity
1380 units
Official record key
device-enforcement:Z-2182-2023

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 CVI4325, UDI/DI (EA) 10653160307037, UDI/DI (CS) 40653160307038; b) Model Number DT13351A, UDI/DI (EA) 10653160325581, UDI/DI (CS) 40653160325582

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.