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.
- Company
- Abbott Laboratories
- Recall Initiated
- June 27, 2008
- Posted
- September 20, 2008
- Terminated
- September 19, 2012
- Recall Number
- Z-2305-2008
- Quantity
- 57,120 units
- Firm Location
- Columbus, OH
Reason for Recall
Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
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.
Lot / Code Info
List #50604 Lot #47822RY Use By DEC 2009
Root Cause
Labeling mix-ups
Action Taken
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.