Class 1 Device Recall Medpro AccuFlo Elastomeric Infusion Device

• Date Initiated by Firm: July 28, 2011
• Date Posted: October 24, 2011
• Recall Status: Terminated on December 19, 2011
• Recall Number: Z-0081-2012
• Recall Event ID: 59981
• 510(K)Number: K081905
• Product Classification: Pump, infusion, elastomeric - Product Code MEB
• Product: Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
• Code Information: Lot #100924, Exp. 2015-08, Item CT-0020-270C
• Recalling Firm/ Manufacturer: Progressive Medical Inc; 11085 Gravois Industrial Ct; Saint Louis MO 63128-2012
• For Additional Information Contact: Mark M. Martin; 314-961-5786
• Manufacturer Reason for Recall: The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Progressive Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question. Should you have any questions, please call 800-969-6331 or email to dsullivan@progressivemedinc.com.
• Quantity in Commerce: 180 units
• Distribution: Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
• 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 = MEB