FDA recalls organ recovery kits due to low-grade plastic bags

The U.S. Food and Drug Administration (FDA) is spreading awareness of a recall on organ recovery packs, used to transport donations harvested for transplant. An issue with the plastic bags in what are described as “convenience kits,” also containing drugs and instruments used during surgeries, have been deemed “not medical grade,” thus unsafe to use. 

The agency said the manufacturer of the kits, AVID Medical, has already notified known customers about the dangers associated with the faulty polythene bags, urging them to seek a replacement. 

In its notice, AVID Medical said the non-medical-grade materials could transfer toxic substances to the organs that increase the risk of rejection after transplantation, or may render any tissue unviable. 

As both the company and the FDA noted, lower-grade plastics sometimes contain unwanted additives, heavy metals or other substances that could be detrimental to human health. Further, the bags are not sealing properly on the bottom, increasing the risk that microbes from the outside can enter the sterile environment inside the bag.  

To date, there have been no reported medically significant adverse events associated with this manufacturing error. A single incident of “loss of containment” was reported to the FDA, resulting from the issues described above. 

Due to the serious risk to patient safety, this recall has been designated a Class I—the most serious type.