Recall Z-0080-2012 ยท MEB Pump, Infusion, Elastomeric
Victus, Inc.
"***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-o
| Date | Oct 24, 2011 (initiated Sep 20, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 63 units |
| Distribution | USA (nationwide) including Puerto Rico and the states of FL and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.