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Class 1 Device Recall Elastomeric Infusion Pump |
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Date Initiated by Firm |
September 20, 2011 |
Date Posted |
October 24, 2011 |
Recall Status1 |
Terminated 3 on January 12, 2012 |
Recall Number |
Z-0080-2012 |
Recall Event ID |
59984 |
Product Classification |
Pump, infusion, elastomeric - Product Code MEB
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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 FL 33155-4400
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For Additional Information Contact |
Ileana Yanes 305-663-2129
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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.
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FDA Determined Cause 2 |
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
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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.
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