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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:119619

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.

Official recall number

Z-1678-2013

Evidence summary

Product code
MEB
Recall status
Terminated
Event initiated
July 31, 2009
Root cause
Equipment maintenance
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1678-2013

Field note

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