Enforcement Report - Week of November 7, 2012
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Product Detail
| Product Description | Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy. |
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| Recall Number | Z-0161-2013 |
| Classification | Class I |
| Code Info | AccuFlux, Lot#: 91209. |
| Product Distributed Qty | 500 units |
| Reason For Recall | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ¿15%. |
Event Detail
| Event Id | 60030 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | First Medical Source LLC |
| City | Laguna Beach |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-07-09 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | US Nationwide distribution in the state of IL |
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