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U.S. Department of Health and Human Services

Class 1 Device Recall WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP

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  Class 1 Device Recall WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP see related information
Date Initiated by Firm October 20, 2011
Date Posted November 23, 2011
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0267-2012
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 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.
Code Information Lot 90225 Exp 01/2012,  Lot 90514 Exp 04/2012,  Lot 90517 Exp 04/2012.    
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 2		 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 8 cases (192 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 and Original Applicant = Westmed, Inc.
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