Recall Z-0145-06 ยท FRN Pump, Infusion
Abbott Laboratories
Fleixiflo Quantum Enteral Pump.
| Date | Nov 16, 2005 (initiated Oct 7, 2005) |
| Status | Terminated |
| Reason | Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula. |
| Root cause | Other |
| Action | The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05. |
| Quantity | 24 devices |
| Distribution | The device was distributed to 11 hospitals, 5 medical supply customers, and 3 nursing homes located in AL, CA, IN, LA, MI, NC, NH, NY, OH, OK, PA, SC, TN, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP Abbott Mfg., Inc., Jul 24, 1995 |