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Around 100 baby deaths have been linked to a recalled Fisher-Price sleeper.
The company recalled 4.7 million Rock 'n Play sleepers in 2019 after more than 30 infants were reported to have died in the Rock 'n Play Sleepers after rolling from their backs to their stomachs or sides while unrestrained.
Since then, approximately 70 more deaths have been added to this figure, including at least eight which occurred following the initial recall, the Consumer Product Safety Commission (CPSC) announced on Monday (9 January).
"Consumers should stop using the Rock 'n Play immediately and contact Fisher-Price for a refund or voucher," the CPSC said.
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"It is illegal to sell or distribute the recalled sleepers."
CPSC Commissioner Richard Trumka blasted the company in the wake of the additional infant deaths.
In a statement, he said: "Fisher-Price's Rock 'n Play recall was not good enough to remove these products from homes.
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"The incentives Fisher-Price offered were inadequate to draw in enough consumers, and the hurdles were too many. Now, eight infants have died after the recall."
Ynon Kreiz, Mattel's CEO - who joined the company in 2018 - issued an apology in 2021.
He said: "On behalf of myself and everyone at Mattel, I want to convey my deep and sincere condolences to parents and anyone affected by the heartbreaking tragedies.
"I am a father of four children, and I can only imagine that there cannot be a more terrible loss than that of a child."
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In a statement, a Fisher-Price spokesperson told Daily Mail: "There is nothing more important to Fisher-Price than the safety of our products and the trust consumers place in us. Our hearts go out to every family who has suffered a loss.
"The Rock 'n Play Sleeper was designed and developed following extensive research, medical advice, safety analysis, and more than a year of testing and review. It met or exceeded all applicable regulatory standards.
"As recently as 2017, the U.S. Consumer Product Safety Commission (CPSC) proposed to adopt the ASTM voluntary standard for a 30-degree angled inclined sleeper as federal law."
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The statement continued: "After the product launched, different independent medical and other expert analyses verified that it was safe when used in accordance with its instructions and warnings.
"Two studies confirmed that the Rock 'n Play Sleeper was as safe or safer than other sleep environments such as cribs and bassinets, and one of the studies found that the product had far fewer incidents than the SUID rates in cribs, bassinets, and playpens.
"In addition, we reported significant incidents to the CPSC beyond the requirements of the Consumer Product Safety Act.
"Though the facts show the Rock 'n Play Sleeper was safe when used in accordance with its instructions and warnings, we voluntarily recalled it in 2019 and have continued to work diligently to remove all recalled product from the market. We reaffirm our commitment to parents that we will always put their children's safety first."
Jake Massey