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Recall Observatory FDA recall evidence

Device product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725

Z-2189-2023

May 18, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92466
Status
Ongoing
Classification
Class II
Quantity
316 units
Official record key
device-enforcement:Z-2189-2023

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 CDS840214P, UDI/DI (EA) 10193489443196, UDI/DI (CS) 40193489443197; b) Model Number DYNJ82725, UDI/DI (EA) 10195327207380, UDI/DI (CS) 40195327207381

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.