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Cardinal Health Recall 91087

Description: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

Cardinal Health Recall 91087 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0356-2023
Event ID91087
Event DescriptionDover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
Product TypeDevices
DistributionNationwide
Recall ReasonOcclusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Device Classification20221214
Device Code InfoUDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764
Center Classification Date20221202
Recall Initiation Date20221101
Recalling FirmCardinal Health
Initial Notification Letter
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