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Volcano Corp Recall 90292

Description: Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Volcano Corp Recall 90292 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1270-2022
Event ID90292
Event DescriptionPhilips OmniWire Pressure guide wire REF 89185J PN 300000252891
Product TypeDevices
DistributionU.S.: WA and WI O.U.S.: Canada
Quantity11 devices
Recall ReasonDue to a potential failed sterilization process.
Device Classification20220622
Device Code InfoModel Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719
Center Classification Date20220616
Recall Initiation Date20220516
Recalling FirmVolcano Corp
Initial Notification Letter
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