Devices

Device Recall ONQ pump with ONDEMAND bolus button

Model / Serial
Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
Product Description
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. || Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. || Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
Manufacturer
I-Flow Corporation
1 Event
- Recall of Device Recall ONQ pump with ONDEMAND bolus button

Manufacturer

I-Flow Corporation

Manufacturer Address
I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
Source
USFDA

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