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Recall Observatory FDA recall evidence

Device product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472

Z-2204-2023

May 18, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92466
Status
Ongoing
Classification
Class II
Quantity
24192 units
Official record key
device-enforcement:Z-2204-2023

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: Model Number DYND41472, UDI/DI (EA) 10080196996537, UDI/DI (CS) 40080196996538

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.