Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
FDA device recall Z-1238-2007 · posted 2007-09-27 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- A software defect could allow up to 50mL of extra volume being added to a TPN solution.
- Action taken
- All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.
- Root cause
- Other
- Status
- Terminated
- Product code
- NEP
- Quantity affected
- 30 units
- Distribution
- Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
- Date initiated
- 2007-06-27
- Date posted
- 2007-09-27
- Date terminated
- 2007-12-07
- Location
- Englewood, CO
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