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 Recall Z-2305-2008 · Posted 2008-09-20
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeLZH
Date Initiated2008-06-27
Date Terminated2012-09-19
Product Quantity57,120 units
Reason for Recall
Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
Firm 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.
Root Cause
Labeling mix-ups
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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