EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200
FDA device recall Z-1963-2014 · posted 2014-07-01 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
- Action taken
- An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 1758
- Distribution
- US Nationwide
- Date initiated
- 2014-06-10
- Date posted
- 2014-07-01
- Date terminated
- 2017-02-22
- Location
- Deerfield, IL
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