Intravenous products: Medpage Today report “In earlier Class I recall of saline flush syringes has now prompted a secondary recall of venous catheter trays that included the defective syringes, the FDA said. Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.
The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9% sodium chloride) manufactured by Excelsior Medical Inc. Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.
After learning of the problem, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.
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