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Uromedica Inc. Recall 89184

Description: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

Uromedica Inc. Recall 89184 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0458-2022
Event ID89184
Event DescriptionUROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Quantity18 devices
Recall ReasonThe U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Device Classification20220112
Device Code InfoLot numbers UM00794 and UM00817, UDI 00180668000106
Center Classification Date20220105
Recall Initiation Date20211122
Recalling FirmUromedica Inc.
Initial Notification Letter
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