Recall Z-0607-2014 ยท NEP System/Device, Pharmacy Compounding
Baxter Healthcare Corp.
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
| Date | Dec 29, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled. |
| Root cause | Nonconforming Material/Component |
| Action | A Service Bulletin was sent to all IntelliFill i. v. customers February 22, 20 I 0 by USPS mail. The Service Bulletin informs customers that IntelliFill i.v. operators are to be trained to listen for the running HEPA filtration fan motor and observe/feel for airflow coming from the automation deck. The field service engineer dispatched to the site replaced the damaged sensor on 11-Feb-2010 and a Service Bulletin was sent to all customers regarding the function and use of the HEPA filter on 22-Feb-2010. A new HEPA sensor was designed and installed into all current IntelliFill i.v. devices be |
| Quantity | 28 devices |
| Distribution | Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.