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U.S. Department of Health and Human Services

Class 2 Device Recall Flexiflo Quantum Enteral Pump

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  Class 2 Device Recall Flexiflo Quantum Enteral Pump see related information
Date Initiated by Firm August 18, 2004
Date Posted March 08, 2005
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-0570-05
Recall Event ID 29856
510(K)Number K944669  
Product Classification Pump, Infusion, Enteral - Product Code LZH
Product Flexiflo Quantum Enteral Pump
Code Information Serial #1061305 through 1061455 Serial #1061486 through 1061505 Serial #1061507 through 1061512 Serial #1061705 through 1061726
Recalling Firm/
Ross Products Division Abbott Laboratories
625 Cleveland Ave
Columbus OH 43215-1754
For Additional Information Contact Randal P. McCay
Manufacturer Reason
for Recall
Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
FDA Determined
Cause 2
Action The firm contacted all consignees via telephone and letter on 08/18/2004.
Quantity in Commerce 199 individual serial numbered units
Distribution Products were distributed to the following states nationwide: MA, NJ, NY, PA, MD, VA, NC, SC, GA, FL, CA, TN, KY, OH, MI, SD, IL, KS, LA, AR, OK, TX, and CO.
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 MFG., INC.