Key Summary
- Mölnlycke Health Care recalls Hibiwash batches over microbial contamination (no harm reported).
- Around 50,000 units affected; patients told to stop use and return stock.
- Risk low but caution for vulnerable groups; report issues via MHRA Yellow Card Scheme.
Mölnlycke Health Care has recalled three batches of its antimicrobial wash Hibiwash, as a precautionary measure under the MHRA Class 2 recall, following the detection of microbial contamination at its manufacturing facility.
Although no patient harm occurred, the recall was announced after Burkholderia cepacia was found during a routine weekly inspection.
Batch numbers 5156042, 5156043, and 5156093 with nearly 50,000 units are recalled, urging all healthcare professionals and retailers to return the remaining stock to the suppliers.
Patients who have purchased the wash from any of these batches must stop using it immediately.
Alternative chlorhexidine gluconate 4 per cent washes are available to use.
Cystic fibrosis patients and patients awaiting lung transplant, who have bought Hibiwash since 10 February this year, will be contacted directly to ensure their safety.
Burkholderia cepacia is a low-risk contamination, but it can cause dangerous side effects to vulnerable people.
“If you have used the product and are concerned that you may be vulnerable to infection or have experienced an adverse reaction, please seek medical advice,” said Shareen Doak, deputy director, Benefit-Risk Evaluation, at the Medicines and Healthcare products Regulatory Agency (MHRA).
Doak added, “Any suspected adverse reactions can be reported to the MHRA through the MHRA’s Yellow Card Scheme.”
