Becton Dickinson subsidiary CareFusion recalled some IV sets today after reports that cracks in the secondary set back-check valve caused infusion fluid to leak. The company said the secondary sets are attached to a needle-free device that has been cleaned with isopropyl alcohol and CareFusion thinks that causes the plastic to crack.
Leakage in the back-check valve connection could unintentionally delay the start of infusion, expose patients to chemicals, cause under-infusion without an alarm or interrupt infusion, CareFusion reported.
The company performed tests on the back-check valves and demonstrated that 70% isopropyl alcohol can affect the integrity of the valve and lead to cracking. The investigation demonstrated that the valve’s material has low resistance to the cleanser.
The supplier of the valve’s material reportedly confirmed that the plastic has limited alcohol resistance.
In the urgent field safety notice, CareFusion told customers to inspect their products and destroy any that fall under the affected lot numbers.
In February, the U.K.’s Medicines & Healthcare Products Regulatory Agency issued an 2nd warning for CareFusion’s Alaris drug pump after the company discovered that the Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication.
The UK watchdog 1st warned customers in December last year that the pump could release a dose of medication if it was used with non-recommended syringes.
