Class 2 Device Recall Fleixiflo Quantum Enteral Pump.

• Date Initiated by Firm: October 07, 2005
• Date Posted: November 16, 2005
• Recall Status: Terminated 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: 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