IA#33-04 2/16/89
TYPE OF ALERT: Automatic Detention
PRODUCT : Candy Pacifiers (gummy pacifiers)
PRODUCT CODE : 33L[][]07
PROBLEM : Adulterated, unfit for food. (Severe health hazard in toddlers
and infants in that product could result in asphyxiation)
PAC : 03819A
COUNTRY : All
MANUFACTURER/
SHIPPER : All
CHARGE : "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be unfit for food
[adulteration 402(a)(3)]."
RECOMMENDING
OFFICE : CFSAN, HFF-310
REASON FOR
ALERT : Samples of the "Gummy Pacifier" were collected by KAN-DO under
DI89-551-248, 304/305 from a dealer in Iowa. The manufacturer
of the "Gummy Pacifiers" is Wilk. Schmitz-Scholl, Federal
Republic of Germany. Initially, seizure of the product was
recommended because management refused to recall or stop sales
of the product.
Examination and evaluation of the "Gummy Pacifier", on
December 21, 1988, by the Health Hazard Evaluation Board (HEE
No. 2144) concluded that the size and the shape of the product
tended to increase the likelihood of it lodging in the upper
airway and producing partial or complete obstruction. In
addition, when this type of product becomes wet, it is very
slippery which enhances the chance of asphyxiation. It was
the Board's opinion that candy pacifiers present a potential
choking hazard to infants and small children. (In 1974 the
Board made a similiar evaluation of candy pacifiers.)
On December 27, 1988, the firm's president, accompanied by
legal counsel, met at CFSAN to discuss the status of the
samples. After being informed of the health hazard evaluation,
firm representatives agreed that a recall was warranted and
would be started promptly. Lots of remaining stock and those
recalled will be re-exported to the Federal Republic of
Germany in accordance with Section 801(d) of the Act.
INSTRUCTIONS : Automatically detain all candy pacifiers, including product
labeled as "Gummy Pacifiers", from all countries and all
manufacturers/shippers.
FOI : No purging required.
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