Recall Z-0377-04 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions; Baxter Healthcare Corporation, Clintec Nutriiton Division, Deerfield, IL 60015 USA
| Date | Jan 29, 2004 (initiated Dec 16, 2003) |
| Status | Terminated |
| Reason | The compounder may omit an ingredient during the compounding process. |
| Root cause | Other |
| Action | Baxter telephoned the accounts on 12/16/03, informing them of the potential for the Micromix BCR to omit an ingredient during the compounding process. The accounts were instructed to cease use of the Micromix BCR and return the units to Baxter via next day delivery. |
| Quantity | 6 units |
| Distribution | Wisconsin and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.