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U.S. Department of Health and Human Services

Class 1 Device Recall Elastomeric Infusion Pump

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 Class 1 Recall
Elastomeric Infusion Pump
see related information
Date Posted October 24, 2011
Recall Status1 Terminated on January 12, 2012
Recall Number Z-0080-2012
Recall Event ID 59984
Premarket Notification
510(K) Number
K081905 
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Sriracha, Chonburi 20230, Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***" Packed 24 units per case. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Code Information Lot 100533
Recalling Firm/
Manufacturer
Victus, Inc.
4918 SW 74th Ct
Miami, Florida 33155-4400
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ileana Yanes
305-663-2129
Manufacturer Reason
for Recall
Victus, Inc. Miami, FL is recalling Vipat Brand Elastomeric Infusion Pump, Model H0020-100, Lot 100533. The product may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to patients.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Victus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 15, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use, remove the products from inventory and quarantine the products. Additionally, the firm indicated that their customer service department would contact customers to coordinate the return of affected products. Customers are directed to call 305-663-2129 ext. 110 for questions regarding this notice.
Quantity in Commerce 63 units
Distribution USA (nationwide) including Puerto Rico and the states of FL and PA.
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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