Class I — First Medical Source LLC
| Recalling firm | First Medical Source, LLC |
|---|---|
| Registered facility | FIRST MEDICAL SOURCE (THAILAND) CO., LTD (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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 pr |
| Product | 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. Me… |
| Quantity | 500 units |
| Distribution | US Nationwide distribution in the state of IL |
| Initiated | 2011-07-09 |
| Classified | 2012-11-27 |
| Terminated | 2014-09-22 |
| Recall number | Z-0161-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — First Medical Source LLC (Z-0161-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/60030/
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