The FDA has identified a recent recall on normal saline flush syringes (Nurse Assist Inc.) as Class I.
This is the agency’s most serious type of recall, where “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recall was initiated due to incidents of Burkholderia cepacia contamination.
B. cepacia can cause bloodstream infections and death, according to the FDA. The bacteria pose little medical risk to healthy people, but individuals with weakened immune systems or chronic lung diseases such as cystic fibrosis may be more susceptible to infections, and the bacteria are often resistant to common antibiotics, according to the CDC.
The 12-mL plastic syringes are filled with 3, 5 or 10 mL of 0.9% sodium chloride. Health care providers who used the syringe and patients who used devices cleared by the syringe may be affected.
The nationwide recall includes 386,175 syringes. The lot numbers are 1203, 1205, 1210 and 1210-BP. The syringes were manufactured from Sept. 24, 2015, to Aug. 1, 2016, and distributed from Feb. 16 to Sept. 30, 2016.
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