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U.S. Department of Health and Human Services

Class 1 Device Recall Medpro AccuFlo Elastomeric Infusion Device

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 Class 1 Recall
Medpro AccuFlo Elastomeric Infusion Device
see related information
Date Posted October 24, 2011
Recall Status1 Terminated on December 19, 2011
Recall Number Z-0081-2012
Recall Event ID 59981
Premarket Notification
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, Missouri 63128-2012
Consumer Instructions Contact the recalling firm for information
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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = Westmed, Inc.
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