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U.S. Department of Health and Human Services

Class 2 Device Recall Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag

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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 Status1 Open
Recall Number Z-2305-2008
Recall Event ID 48725
Premarket Notification
510(K) Number
K915735 
Product Classification Pump, Infusion, Enteral - Product Code LZH
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
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Randal P. McKay
614-624-3688
Manufacturer Reason
for Recall
Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = ABBOTT LABORATORIES
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