Note: Replacements are no longer available. Do not use these products. Please discard or destroy these products.
FOR IMMEDIATE RELEASE |
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Originally issued June 10, 1985; Revised August 27, 2001 |
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Release # 85-031 |
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Century Products and Product Source Inc. Recall Infant "Crib Cuddle"
WASHINGTON, D.C. -- In cooperation with the U.S. Consumer Product
Safety Commission, Century Products, Inc., of Stow, Ohio and Product
Source, Inc., Of Laguna Hills, California, had a free replacement
program for the infant hammock portion of a product called
Crib Cuddle. Approximately 109,000 Crib Cuddles have been distributed
since 1982. The firms and the Commission are aware of one death and
two near-misses in which a baby under two months of age was found with
his head over an edge of the hammock.
The Crib Cuddle, which retails for approximately $39.95, is a
yellow hammock of soft terry material with a plush pile center and a
red heart-shaped, battery-operated pulsator intended to simulate a
heartbeat-type sound. The hammock has six straps to suspend it from
the side rails of the crib. Product Source distributed the Crib Cuddle
under the trade name Infacare from March 1982 to May 1983. Century
Products had been distributing the Crib Cuddle under the Century name
since June 1983.
All Crib Cuddle owners should immediately stop using the product
and discard or destroy the product. Replacement products are no longer available.
Crib Cuddles sold under the Infacare name, have a small white
tag sewn onto the hammock with the Infacare name on it. Consumers
with Infacare Crib Cuddles should stop using the product
and discard or destroy the product. Replacement products are no longer available.
For additional information, consumers may call the company's customer service number at 800-345-4109 or the Commission's toll-free Hotline,
800-638-CPSC. The teletypewriter number for the hearing-impaired
is 800-638-8270.
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In the Matter of Commission
Ballot Vote on the Corrective
Action Plan for Crib Cuddle
(ID 84-13, 85-15)
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STATEMENT OF VICE CHAIRMAN |
SAUNDRA BROWN ARMSTRONG
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I have carefully reviewed the corrective action plan for Crib Cuddle
which was jointly submitted to the Commission by Product Source, Inc.
(which distributed the product from May 1982 to May 1983 under the
brand name "Infacare") and Century Products, Inc. (which distributed
the product from June 1983 until distribution of the original version
of the product ceased in December 1984). In addition, I have
reviewed other information provided by staff, including human
factors analyses of the original and redesigned versions of the Crib
Cuddle.
The Crib Cuddle came to the attention of the Commission almost a year
ago (June 1984) when the staff learned of the death of a 5-week old
infant in one of the products due to positional asphyxia. Subsequently,
the Commission learned of two "near -misses" involving Crib Cuddles.
Following investigation of these incidents and analysis of the
product, the staff preliminarily determined that Crib Cuddles
(original design) present a substantial risk of injury to infants.
Source, an agreement was reached that the firms would initiate a joint
recall of the product and undertake a combined corrective action
Program. (It should be noted that the firms have already, on their
own initiative, begun implementation of certain activities outlined in
the remedial program.) in addition; Century submitted two prototypes
of new Crib Cuddle designs to the commission for evaluation.
The Crib Cuddle (original design) is a hammock-style device in
Which an infant can be placed for sleeping. Its distributors
recommend its use with infants from birth to three months of age. The
hammock attaches to the side rails of a crib by six adjustable soaps,
three on each side. The product also includes a plastic heart-shaped
box containing a battery-operated! Mechanism which emits a pulsating
sound and vibration. The heart-shaped box is inserted into a soft pad
which is sewn on the hammock.
According to the instruction, when the Crib Cuddle is installed,
the crib mattress should be raised to its highest position so that a
flat base is created on which the baby can lie.
The staff has conducted a limited assessment of the new Crib Cuddle;
however, at this time, they are unable to provide evidence which
confirms the safety of the new design or its performance in actual use
situations. Century Products has commissioned Brown University to
conduct necessary safety tests. These tests are intended to provide
more extensive information concerning infant-product interaction and
will evaluate the performance of the product in more naturalistic
circumstances.
While the corrective action plan proposed by Century Products and
Product Source includes many elements, which I believe will provide
adequate notice, admonitions, and guidance to the public concerning
the risks associated with the original Crib Cuddle, I do not agree
with the Commission staff's recommendation that the commission approve
the corrective action plan and press release in the absence of data
and other information which verifies that the hazards associated with
the original Crib Cuddle are truly eliminated by there designed
version. Because the corrective action plan will also effectuate a
recall process which involves the replacement of the old version of
the product with the redesigned version, approval of the plan in its
present form, in my view, is tantamount to the approval of the
redesigned Crib Cuddle, and, thereby, conveys to consumers the .
mistaken impression that our (limited)'evaluation of the new Crib
Cuddle has confirmed the product's safety.
Given the very unique nature of the product and the extreme
vulnerability of the population at risk, I believe that the Commission
should proceed with caution and take the necessary time and action to
make reasonable determination, based on testing data now being
developed, that the "new and improved" Crib Cuddle does not present a
risk of injury to infants. In the absence of test results validating
the efficacy and safety of the redesigned product, it is, in my view,
premature at best to certify a plan which places in the hands of
consumers a product which has not been fully tested and information
which conveys the impression that the new Crib Cuddle is safe for
infants. Therefore, in this context, I am voting not to approve the
corrective action plan or press release for Crib Cuddle.
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The Crib Cuddle can be dangerous if an infant, in moving about, is
able to, reach the edge of the hammock and place his or her head over
the, edge possibly resulting in suffocation. One death and two near-misses have been reported in which this occurred.
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