Z-0080-2012

"Vipat REF H0020-100Lot 1005332015-04STERILE EO Elastomeric pump2mL/Hr100mL***Medpro...

Name: Z-0080-2012 "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro...
Creator: Victus, Inc.
Published: 2011-09-20
License: https://open.fda.gov/license/

Victus, Inc. / initiated 2011-09-20 / Terminated / root cause: manufacturing process

FDA source

Victus, Inc. began a recall of "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi... on 2011-09-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0080-2012
Status: Terminated
Initiated: 2011-09-20
Posted: 2011-10-24
Terminated: 2012-01-12
Recalling firm: Victus, Inc.
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.
Product code: MEB Pump, Infusion, Elastomeric
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot 100533

Product code MEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)