Strong Recall Documentation Expedites Recall Management Process

By Mike Rozembajgier

A lawsuit filed after the death of a two year old patient demonstrates the integral role that recall documentation can have in product liability litigation. The parents of boy allege that their son’s severe case of bacterial meningitis, which led to his sudden death, was caused by alcohol wipes and swabs used during his medical care. They filed suit against Triad Group, the company that supplied the products, alleging gross negligence. In this case and others like it, recall management practices and recall documentation can be critical.

While the parents have no direct evidence that the alcohol prep products used during their son’s medical procedure were the ones contaminated with Bacillus cereus, the hospital has confirmed that it did indeed use Triad Group’s products in some procedures. The case is still in its earliest stages, and neither the hospital or the company has presented evidence of whether the contaminated products were used during the little boy’s treatment.

This is where careful recall documentation would come into play. Clear documentation can help consumers, retailers and regulators pinpoint the exact timeline of a recall. Documentation offers a roadmap of the recall process from the exact date of the initial recall announcement, to the exact date and time that a specific location was notified, to the time when the organization acknowledged receipt of the information and began sorting its product. In this case, the paper trail can help determine whether the patient was really exposed to the contaminated product, when the hospital first knew of the risk, and whether the company did what was necessary to warn its customers.

Isolating specific points in time for the recall helps situate other important events and recall-related fallout. For instance, consumers who are concerned about whether a product they purchased on a certain day might be affected can be told that they bought the product on day four of the recall, and they can rest assured that all affected product was returned on day three. When litigation is involved, clear documentation can clarify the recall timeline and answer critical questions about who was actually affected.

Recall documentation is a labor-intensive process. In order to do it right, it is best to work with a recall partner that has the tools and expertise to track detailed data accurately, even in large quantities. ExpertRECALL’s experience is so broad that the FDA adopted its notification document package as the regulatory standard. ExpertRECALL’s documentation experience streamlines the process, allowing companies managing a complicated recall to present their documentation to regulators sooner, closing the recall faster, and marshaling evidence that could be very valuable in litigation.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.