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Recall Observatory FDA recall evidence

Device product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTION, Model Number DYNJ63347A; e) TAVR FAIRFAX, Model Number DYNJ63634A; f) PARATHYROID PACK, Model Number DYNJ81389A; g) THYRIOD PACK, Model Number DYNJ83960; h) WMC COCHLEAR IMPLANT ADD ON, Model Number DYNJ907206D

Z-2172-2023

May 18, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92466
Status
Ongoing
Classification
Class II
Quantity
1861 units
Official record key
device-enforcement:Z-2172-2023

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 CDS983069I, UDI/DI (EA) 10195327071868, UDI/DI (CS) 40195327071869; b) Model Number DYNJ30245, UDI/DI (EA) 10080196787692, UDI/DI (CS) 40080196787693; c) Model Number DYNJ47716B, UDI/DI (EA) 10193489454536, UDI/DI (CS) 40193489454537; d) Model Number DYNJ63347A, UDI/DI (EA) 10193489278064, UDI/DI (CS) 40193489278065; e) Model Number DYNJ63634A, UDI/DI (EA) 10195327143046, UDI/DI (CS) 40195327143047; f) Model Number DYNJ81389A, UDI/DI (EA) 10195327176785, UDI/DI (CS) 40195327176786; g) Model Number DYNJ83960, UDI/DI (EA) 10195327319991, UDI/DI (CS) 40195327319992; h) Model Number DYNJ907206D, UDI/DI (EA) 10195327307011, UDI/DI (CS) 40195327307012;

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.

Field note

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