FDA Gives Arrow Final Warning

A recent FDA warning letter to Arrow International for its quality system violations is the company’s final warning prior to regulatory action.

The letter cited “significant regulatory problems” involving Arrow’s catheters and other devices and noted that the agency sent the firm three warning letters in 2005 related to quality system deficiencies.

According to the letter, one of Arrow’s facilities did not perform corrective actions after confirming a 2006 complaint reporting that both parts of a hemodialysis catheter fragmented and migrated into a patient’s pulmonary artery.

The company could not be reached for a comment by press time. The warning letter can be seen at www.fda.gov/foi/warning_letters/s6537c.pdf.