Recall Z-1553-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Sep 21, 2005 (initiated May 3, 2005) |
| Status | Terminated |
| Reason | The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis. |
| Root cause | Other |
| Action | Safety Alert letters dated 5/3/05 were sent to all Flo-Gard 6201 and 6301 Volumetric Infusion Pump customers. The letters informed the users of the potential for the pole clamp mounting screws to come loose, and recommended that they inspect the Flo-Gard pole clamp during their routine maintenance or as part of the recommended annual preventative cycle. If the pole clamp appears to be loose, the users were provided with the following steps to be followed to ensure that the pole clamp is properly secured: a) The recessed area in the housing for the clamp body must be clean. b) The three moun |
| Quantity | 61,759 units |
| Distribution | Nationwide including Puerto Rico, and internationally to Canada, Taiwan, Thailand, Belgium, Switzerland, New Zealand, China, Argentina, Peru, Australia, Asia, Hong Kong and the Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915522 | FLO-GARD(R) 6201 Baxter Healthcare Corp, Feb 28, 1992 |