“Out of abundance of caution” the Triad Group initiated a
recall of all lots of Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks
on January 3, 2011, due to “concerns from a customer about potential
contamination of products with an objectionable organism, namely Bacillus
cereus.”
Triad’s Press Release on January 5, 2011, continued to state
that it had received “one report of a non-life-threatening skin infection.” The
date of this one report was not given. (I suspect we won’t know that date until
a Warning Letter comes out.)
Triad published a fact sheet about the recall on its
website. They stated, “There has been ONE report of a potential contaminant out
of hundreds of millions of products sold.” (Their emphasis, not mine.)
The contaminated product was recalled, but tragically, not
before the product was used with the surgery of a 2-year-old Houston boy who allegedly died from acute
meningitis due to Bacillus cereus on December 1, 2010. Use of the product has
been confirmed. The parents have filed a wrongful death suit. “We’ve been
devastated. We’ve been absolutely crushed.”a
Without going into a bacteriology lecture, suffice it to
say, all the experts have weighed in on what every rank-in-file microbiologist
in the medical products laboratory should know: Bacillus cereus is a very bad
bug. This spore former is resistant to heat and tough to kill. That’s why it’s
called an “objectionable organism”—it doesn’t belong in the product at any level.
“Concerns from a
customer.”—one, just one customer—out of hundred of millions sold—one, just one
customer. In the case of Bacillus cereus, it shouldn’t have to take more than
one to crawl all over the problem.
My message to the Quality Department and those responsible
for responsible for designing or operating the Complaint Handling System
required by 21CFR211.198 and 21CRF820.198—sometimes it only takes one. Some
complaints are so serious and potentially life threatening, that it just takes
one. Don’t look for a trend.
With Triad’s one concerned customer, it’s not whether it was
non-life-threatening to that one customer. Rather, it is all about Bacillus
cereus.
I would have expected the “abundance of caution” at the
Triad Group to be: (1) stop production, (2) recall all product, and (3)
initiate a revalidation of all production lines—upon the first report of Bacillus
cereus.
We don’t know yet the date of when Triad became aware of the
first report. But I don’t get the feeling that the “abundance of caution” was
very abundant.
a JoNel Aleccia, Parents blame toddler’s death on tainted
alcohol wipes, msnbc.com, 2/15/11.
