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U.S. Department of Health and Human Services

Class 2 Device Recall Fleixiflo Quantum Enteral Pump.

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  Class 2 Device Recall Fleixiflo Quantum Enteral Pump. see related information
Date Initiated by Firm October 07, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on August 13, 2007
Recall Number Z-0145-06
Recall Event ID 33736
510(K)Number K944669  
Product Classification Pump, Infusion - Product Code FRN
Product Fleixiflo Quantum Enteral Pump.
Code Information Serial numbers 1003276, 1022603, 1025074, 1027378, 1028541, 1049161, 1056343, 1056908, 1057323, 1057967, 1058939, 1059103, 1059366, 1059614, 1059641, 1059857, 1059892, 1059945, 1060026, 1060188, 1061131, 1061355, 1061492.
Recalling Firm/
Manufacturer
Abbott Laboratories
6550 Singletree Dr
Columbus OH 43229-1119
For Additional Information Contact Randal P. McKay
614-624-3688
Manufacturer Reason
for Recall
Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
FDA Determined
Cause 2
Other
Action The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05.
Quantity in Commerce 24 devices
Distribution The device was distributed to 11 hospitals, 5 medical supply customers, and 3 nursing homes located in AL, CA, IN, LA, MI, NC, NH, NY, OH, OK, PA, SC, TN, VA, and WI.
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 = FRN and Original Applicant = ABBOTT MFG., INC.
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