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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 Device Recall Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag see related information
Date Initiated by Firm June 27, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-2305-2008
Recall Event ID 48725
510(K)Number K915735  
Product Classification Infusion pump - 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 OH 43215-1754
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = ABBOTT LABORATORIES
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