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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196068

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.

Official recall number

Z-0128-2023

Evidence summary

Product code
EZQ
Recall status
Open, Classified
Event initiated
August 16, 2022
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0128-2023