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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-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 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 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 and Original Applicant = Westmed, Inc.
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