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Class 2 Device Recall Flexiflo Quantum Enteral Pump |
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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
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Product Classification |
Pump, Infusion, Enteral - Product Code LZH
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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
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For Additional Information Contact |
Randal P. McCay 614-624-7677
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LZH and Original Applicant = ABBOTT MFG., INC.
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