Recall Z-1054-04 ยท NEP System/Device, Pharmacy Compounding
Baxter Healthcare Corp.
Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy
| Date | Jul 20, 2004 (initiated Apr 26, 2004) |
| Status | Terminated |
| Reason | The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted |
| Root cause | Other |
| Action | Baxter began telephoning their customers on 4/26/04, advising them that an improperly adjusted Vlier pin could result in an ingredient delivery outside of stated accuracy limits. The accounts were requested to immediately stop using the Micromix Compounder and return the device to Baxter, and to evaluate all TPN formualtions that have been compounded but not administered to determine if any ingredients were delivered at a programmed volume of less than 1 mL. The account was advised to discard those solutions and recompound them using manual techniques. Follow-up recall letters were faxed to |
| Quantity | 500 devices |
| Distribution | Nationwide and internationally through Baxter subsidiaries to the United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955622 | AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; Baxter Healthcare Corp, May 6, 1997 |