Recall Z-1371-2012 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration.
| Date | Apr 5, 2012 (initiated Jun 3, 2008) |
| Status | Terminated |
| Reason | Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400. |
| Root cause | Device Design |
| Action | The firm, Baxa, sent a "Exacta-Mix 2400 Compounder Safety Alert" dated June 3, 2008 to all customers. The alert describes the product, problem and actions to be taken. The customers were instructed to not use the main module if any of the 24 valve actuators are damaged; do not infuse any bags if damage is noticed after they have been pumped; do not try to repair or adjust a damaged or bent valve actuator; immediately alert all compounder users of this issue to ensure that when the device is used, the valve actuators are always inspected for damage;" inspect all valve acutators before setup and |
| Quantity | 1000 units (approximately) |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.