Regulatory Focus™ > News Articles > Undeclared Allergens in a Device Lead to Warning Letter, Recall

Undeclared Allergens in a Device Lead to Warning Letter, Recall

Posted 29 October 2013 | By Alexander Gaffney, RAC

US consumers generally are pretty well assured that when they open a product that proclaims to be free or absent of a particular material-and especially one known to cause allergic reactions-that the product will, in fact, be free of that material.

So when that expectation is broken, it tends to be a pretty big deal. The most common problem occurs with food products. A cursory glance at FDA's recent recall notices shows they are rife with events involving undeclared allergens, such as nuts, milk, wheat and soy.

Less common are allergens found to affect healthcare products. However, a Warning Letter released by the US Food and Drug Administration (FDA) on 29 October 2013 details an alarming situation in which a company declared a product to be free of latex when it in fact contained exactly that.

Warning Letter

The letter, dated 30 September 2013, was sent to King Systems Corporation in reference to a July and August 2013 inspection of the company's Noblesville, IN manufacturing facility. The company makes a variety of medical devices at the plant, including its King Flex 2, King F2, King PedF2, and King F Breathing Circuits; as well as the King LT-D and King LTS-D Oropharyngeal Airways.

The problem, FDA said, is that at the time of its inspection, King Systems' facility had a number of deficiencies under 21 CFR 820, better known as FDA's Quality System Regulations (QSR).

One of those deficiencies involved its complaint handling procedures, mandated under 21 CFR 820.198(c), which requires a firm to adequately evaluate (and if necessary investigate) complaints received about a device.  In the case of King Systems, the company was reportedly in receipt of a report indicating that its Universal Flex 2 Breathing Circuit contained latex despite it being labeled as "latex-free."

"This complaint was not investigated despite it involving a failure of device labeling to meet its specifications," the agency wrote. FDA's finding eventually led to a Class I recall of one 40-unit case of the devices on 27 September 2013,

Other Issues

The manufacturer had other problems as well, FDA alleged. Another complaint that went uninvestigated regarded a case that contained the incorrect size of tubing. This event also resulted in a recall after it came to FDA's attention.

Still another purported incident involved the handling of raw materials. FDA investigators cited warehouse bins which contained components which were not listed on physical inventory sheets as being evidence of failure to control storage areas per 21 CFR 820.150(a).

Warning Letter to King Systems

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