On January 4, 2017, the FDA classified the recall of all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia (B. cepacia) bloodstream infections as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
According to the CDC, the effects of B. cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.” Nurse Assist recalled its I.V. Flush Syringes after becoming aware of patients that developed B. cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist.
The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.
The recall affects 386,175 syringes nationwide. Nurse Assist’s 12 mL IV Flush Syringe with a 3 mL, 5 mL, or 10 mL fill volume can be identified by the labeling on the packaging and device. The lots being recalled were manufactured from September 24, 2015, to August 1, 2016, and distributed between February 16, 2016, and September 30, 2016. Recalled products include all lots of product codes 1203, 1205, 1210 and 1210-BP.
See the FDA Safety Alert
See the FDA Recall Notice
See also Medical Law Perspectives June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections
See also Medical Law Perspectives October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication