'LATEX FREE' DEVICES CONTAINED LATEX, WARNING LETTER SAYS
Medex labeled two of its devices "latex free" but had to recall the devices because they contained latex, the FDA said in a Sept. 5 warning letter.
The company recalled the CVP Manometer and MX6160R1 Ciper devices in 2005 because they contained latex adhesive tape, an action the FDA said was a Class II recall. The firm failed to submit a written report of the recall, said the warning letter, which was posted recently to the FDA website.
During its inspection March 20 to April 6, the agency also determined that Medex failed to validate a device design to ensure conformance to defined user/patient needs and intended uses.
Medex's needleless split septum injection site design validation did not show that the input requirement of being able to function fully with any access cannula was met, the letter said. The validation testing was only conducted using one type of cannula, without evidence that testing using this type of blunt cannula is representative of the blunt cannulas made by other manufacturers.
Also, the firm said the possibility that the housing of the pre-split septum could come apart or crack was a hazard. This was to be avoided by testing the septum with different styles of cannulas, but the testing was not performed, the FDA said.