Class 1 Device Recall WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP

• Date Initiated by Firm: October 20, 2011
• Date Posted: November 23, 2011
• Recall Status: Terminated on April 25, 2012
• Recall Number: Z-0269-2012
• Recall Event ID: 60316
• 510(K)Number: K081905
• Product Classification: ELASTOMERIC INFUSION PUMP - Product Code MEB
• Product: Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr. Model # CT-0020-270 Item # RFC270020. Manufactured by Medpro International (Thailand) Ltd.
• Code Information: Lot 90228 Exp 12/2012, Lot 90516 Exp 04/2012, Lot 90763 Exp 06/2012
• Recalling Firm/ Manufacturer: Wolf Medical Supply Inc.; 13951 Nw 8th St; Fort Lauderdale FL 33325-6251
• Manufacturer Reason for Recall: Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
• FDA Determined Cause: Process control
• Action: On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.
• Quantity in Commerce: 24 cases (576 units)
• Distribution: Nationwide distribution, including Puerto Rico.
• 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