Safety information on possible contamination of the non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, and “Sono plus Ultraschall gel” of the manufacturer Ultragel Medical Kft.
Safety warnings
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Medical devices
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11/12/2024
**UPDATE 17.12.2024**
The Federal Office for Safety in Health Care (BASG) warns against a potential Contamination of non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, “Sono plus Ultraschall gel“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-04 to 2024-10.
It has been determined that the respective non-sterile ultrasound gels may be contaminated by the bacteria Burkholderia (B.) stabilis ST1565. This may lead to infections, especially concerning immunocompromised persons, persons with cystic fibrosis or intensive care patients.
The BASG has so far received no reports of cases of damage from Austria.
| Medical devices | Non-sterile ultrasound gel “AquaUltra Clear” and “AquaUltra Basic” |
|---|---|
| Manufacturer | Ultragel Medical Kft. |
| Batch number(s) | 2024-04 to 2024-10 |
| Corrective actions | BASG recommends checking the LOT numbers on the packaging of the ultrasound gel to ensure safety. If a product is affected, it must be quarantined according to the manufacturer. Please stop using the affected products immediately to avoid possible health risks from infections due to potential contamination by Burkholderia (B.) stabilis ST1565. |
| Classification of the recall | Class I |
| BASG reference number | 3688655 |
| Company letter (pdf) Link | Field Safety Notice of the manufacturer |
Further inquiry note
Page last modified:
11/12/2024