Class 2 Device Recall Flexiflo Quantum Enteral Pump

• Date Initiated by Firm: August 18, 2004
• Date Posted: March 08, 2005
• Recall Status: Terminated 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/ Manufacturer: Ross Products Division Abbott Laboratories; 625 Cleveland Ave; Columbus OH 43215-1754
• For Additional Information Contact: Randal P. McCay; 614-624-7677
• 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: Other
• 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