A medical kit and tray maker received an FDA warning letter after it switched the size of safety pins in one of its circumcision trays.
Medical Action Industries ran out of existing safety pins for a tray so a larger safety pin was substituted, the letter said. After the change, the company received at least two customer reports of excessive bleeding.
The letter noted that the product family coordinator made the change but did not sign the product authorization form or proceed through the change process.
The company’s latest response to this complaint appears to be adequate, the letter said.
The warning letter, posted recently to the FDA website, can be seen at www.fda.gov/foi/warning_letters/s6660c.pdf.