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No image published for this recall

Soap bubbles “BUBBLE KID”

Official notice

24 Dec 2010

Last checked

24 Dec 2010

Critical riskEU Safety Gate

An official EU Safety Gate notice concerns Soap bubbles “BUBBLE KID”. The product poses a chemical risk because the liquid exceeds the limit values for the total aerobic microbial count (TAMC) (aerobic mesophilic bacteria) laid down by the European Pharmacopoeia for the microbiological quality of non-sterile pharmaceutical preparations (5.1.4), for which cutaneous, nasal or oromucosal contact is envisaged; we consider that the same limit (10²) should apply, since there is equivalence between the exposure experienced by children using the soap bubble toy (this actually occurs through cutaneous contact, through indirect inhalation and through frequent accidental introduction into the mouth during use) and the exposure envisaged for the preparations referred to above. The liquid also returns a positive result for gram-negative bacteria, among which Burkholderia cepacia has been identified; this is highly resistant to antibiotics and is capable of causing infections, including serious infections, in vulnerable subjects such as children with cystic fibrosis or immunodeficiciency disorders. Published 2010-12-24.

What to do now

The source does not provide specific consumer instructions. Follow the official EU Safety Gate notice for next steps.

Recall number

1894/10

Official notice

2010-12-24

The hazard

The product poses a chemical risk because the liquid exceeds the limit values for the total aerobic microbial count (TAMC) (aerobic mesophilic bacteria) laid down by the European Pharmacopoeia for the microbiological quality of non-sterile pharmaceutical preparations (5.1.4), for which cutaneous, nasal or oromucosal contact is envisaged; we consider that the same limit (10²) should apply, since there is equivalence between the exposure experienced by children using the soap bubble toy (this actually occurs through cutaneous contact, through indirect inhalation and through frequent accidental introduction into the mouth during use) and the exposure envisaged for the preparations referred to above. The liquid also returns a positive result for gram-negative bacteria, among which Burkholderia cepacia has been identified; this is highly resistant to antibiotics and is capable of causing infections, including serious infections, in vulnerable subjects such as children with cystic fibrosis or immunodeficiciency disorders.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Models

CODE NO: B0019;

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Affected products

Product 1

Soap bubbles

Risk / hazard

The product poses a chemical risk because the liquid exceeds the limit values for the total aerobic microbial count (TAMC) (aerobic mesophilic bacteria) laid down by the European Pharmacopoeia for the microbiological quality of non-sterile pharmaceutical preparations (5.1.4), for which cutaneous, nasal or oromucosal contact is envisaged; we consider that the same limit (10²) should apply, since there is equivalence between the exposure experienced by children using the soap bubble toy (this actually occurs through cutaneous contact, through indirect inhalation and through frequent accidental introduction into the mouth during use) and the exposure envisaged for the preparations referred to above. The liquid also returns a positive result for gram-negative bacteria, among which Burkholderia cepacia has been identified; this is highly resistant to antibiotics and is capable of causing infections, including serious infections, in vulnerable subjects such as children with cystic fibrosis or immunodeficiciency disorders.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

DE · Germany

Location 2

FR · France

Affected area 1

DE · Germany

Affected area 2

FR · France

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: “bubble Kid”.

Source & status

Tier

beta

Category

KIDS

Classification

Serious risk — Microbiological

App estimate

critical

Recall details

Recall number

1894/10

Classification

Serious risk — Microbiological

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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