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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:181321

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

Official recall number

Z-1977-2020

Evidence summary

Product code
FMF
Recall status
Terminated
Event initiated
April 23, 2020
Root cause
Packaging
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1977-2020

Field note

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