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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag		see related information
Date Posted September 20, 2008
Recall Number Z-2305-2008
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.
Code Information List #50604 Lot #47822RY Use By DEC 2009
Recalling Firm/
Manufacturer		 Abbott Laboratories
625 Cleveland Ave
Columbus, Ohio 43215-1754
For Additional Information Contact Randal P. McKay
614-624-3688
Reason for
Recall		 Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
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 in Commerce 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.
 
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