—#72003

Product

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.

FDA product code: LZH — Pump, Infusion, Enteral
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915735
Affected lot / code info: List #50604 Lot #47822RY Use By DEC 2009

Why it was recalled

Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 625 Cleveland Ave, Columbus, Ohio 43215-1754

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-06-27
Posted by FDA: 2008-09-20
Terminated: 2012-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72003. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.