Reported Dec 5, 2012 · Terminated
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients…
First Medical Source LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: First Medical Source LLC · 28581 Springfield Dr · Laguna Beach, CA · 92677-1424
Is this the product you have?
- Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H
- Product UsageThe 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
- Lot codes and dates
- AccuFlux, Lot#: 91209.
- Amount recalled
- 500 units
Where it was sold
- Nationwide
- IL
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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