Covidien warns customers in the U.S. and Bermuda that some of its Monoject syringes were mislabeled and not properly sterilized, prompting the company to recall 6 lots of the device.
The issues affected 6 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.
The problematic Monoject pre-fill syringes were filled with water and then never properly sterilized. Products labeled as either sodium chloride flush or heparin lock flush might also have mismatched labels between the syringe cap and other parts, according to Covidien.
These problems could lead to serious harm if the patient is injected with non-sterile fluid, which might lead to infection, or if the patient is mistakenly given a water injection, which might lead to blood clots, according to a recall notice.
The Mansfield, Mass.-based device maker sent out the voluntary recall notice this week, asking customers to identify and return affected lots for credit.
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