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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:167284

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Official recall number

Z-3278-2018

Evidence summary

Product code
GAD
Recall status
Terminated
Event initiated
September 04, 2018
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-3278-2018

Field note

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