Infusion sets recalled due to potentially dangerous defect
The Curlin Infusion Administration Set, used to deliver a variety of medicines and other fluids into patients, is being recalled by the manufacturer because of a potential defect that can cause the pump segment to work in reverse. This malfunction can reverse the flow of medicines or fluids, and cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy. This recall is listed as a Class 1 because use of the defective device may result in serious health consequences, including death.
The recall affects certain Curlin Infusion Administration Sets made by MOOG Medical Devices Group based in Salt Lake City, Utah. The products are used in hospital and other healthcare settings as well as in the home. MOOG has contacted customers and distributors by letter and instructed patients in the home environment and health care facilities to contact their home health care provider, clinician or distributor for proper handling and replacement process for the affected administration set.
Any side effects or adverse effects from this or any other medical device or products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA
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