Device evidence

device-recall:cfres:136204

Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Official recall number

Z-1941-2015

Evidence summary

Product code: FGE
Recall status: Terminated
Event initiated: April 27, 2015
Root cause: Employee error
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1941-2015