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ConvaTec, Inc Recall 90856

Description: ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.

ConvaTec, Inc Recall 90856 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0129-2023
Event ID90856
Event DescriptionConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity3209 units
Recall Reasonimpaired functionality of the release liner
Device Classification20221102
Device Code InfoUDI/DI: 768455102891, Batch numbers: 2A03487, 2B00300
Center Classification Date20221024
Recall Initiation Date20220816
Recalling FirmConvaTec, Inc
Initial Notification Letter
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