Recall Z-2269-2012 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed fo
| Date | Aug 24, 2012 (initiated Mar 4, 2011) |
| Status | Terminated |
| Reason | Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches .01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum |
| Root cause | Nonconforming Material/Component |
| Action | Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers |
| Quantity | 19,380 units |
| Distribution | 45,865 units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930459 | BARD MINI-INFUSER 1500 & 3000 Bard Medsystems Div., Aug 10, 1993 |