Recall Z-1112-2007 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064
| Date | Jul 28, 2007 (initiated Jun 21, 2007) |
| Status | Terminated |
| Reason | Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer. |
| Root cause | Other |
| Action | Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing. *** Baxter expanded the recall and telephoned the dire |
| Quantity | 144 pumps |
| Distribution | Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915523 | FLO-GARD(R) 6301 Baxter Healthcare Corp, Feb 28, 1992 |