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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:181416

Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Official recall number

Z-1989-2020

Evidence summary

Product code
KOD
Recall status
Terminated
Event initiated
April 30, 2020
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1989-2020

Field note

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