The FDA announced earlier this week that
Luv n' Care was voluntarily recalling all Nuby liquid-filled teethers due to test samples being found to be contaminated by two types of bacteria. As always, there's more to the story.
ZRecs readers may hear echos here of a
Canadian recall of 125,000 Nuby teethers in June. We don't announce all U.S. children's product recalls on Z Recommends (you can get those
from the CPSC or sign up to
get notifications here via Twitter) but this one seemed different. In addition to our general curiosity about how these U.S. and Canadian recalls might be related, the Food and Drug Administration's recall notice left us with some unanswered questions. So we spoke with management at Nuby's parent company, Luv n' Care, to get the details.
Canada's standard for liquid-filled teethers is more stringent than those applied in the U.S.. Our neighbor to the north requires the water in teethers to be sterile, i.e. to be free of all bacteria. U.S. (FDA) standards use two alternative tests - one to ensure that the preservative added to the liquid in teethers kills any bacteria that is introduced to the liquid, and another to test the liquid itself for the presence of certain strains of bacteria that are considered dangerous enough to be banned. In other words, there are certain bacteria that can be found in a teether in the U.S. and still be legally sold.
Health Canada recalled 125,000 of Nuby's teethers distributed in that country for failing their own standard, i.e. containing bacteria, period; in that case,
Bacillus cereus, explaining that the bacteria was not thought to be dangerous to the general population, but could cause "stomach pain, vomiting, and diarrhea" in those with a compromised immune system.
After the recall was announced, the FDA contacted Luv n' Care and asked them to have some tests performed. Teethers were tested from two "batches" (according to company executive Joseph Hakim, the number of products in a "batch" varies, but can number in the thousands). In the samples tested from one batch, they found one type of bacteria,
Bacillus subtilis. In samples from the other batch, they found
Bacillus circulans. Both of these appear to pose the same level of risk as the strain found in the Canadian case.
These weren't the bacterial strains the FDA was looking for, and they were, technically speaking, permissible, but Luv n' Care opted to issue a recall of some 30 batches of liquid-filled teethers - everything on the U.S. market at present - and
will take back older liquid-filled teethers as well. The FDA's language on the threat posed by this bacteria mirrored that of the Canadian recall.
Mr. Hakim confirmed for Z Recommends that the teethers subject to both the Canadian and U.S. recalls were produced in the same overseas factory. He stated that Luv n' Care would be looking at their manufacturing practices, and that the company would probably
irradiate all of the recalled merchandise it received from stores (the stuff that hadn't been sold yet), so it could then be shipped back out to be sold.
We'll be flagging Nuby liquid-filled teethers in the
ZRecs Guide, where product listings seemed destined to evolve into a historical record of recalls and other safety notes as well as offering product descriptions and ratings. Expect these changes in the Guide over the course of the next week or so.