Recall Z-2305-2008 ยท LZH Pump, Infusion, Enteral
Abbott Laboratories
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
| Date | Sep 20, 2008 (initiated Jun 27, 2008) |
| Status | Terminated |
| Reason | Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set." |
| Root cause | Labeling mix-ups |
| Action | On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance. |
| Quantity | 57,120 units |
| Distribution | Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915735 | FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT Abbott Laboratories, Jun 24, 1992 |