Important Safety Alerts

Medical device manufacturer, Laboratoires Anios, has issued a medical device safety alert concerning its ANIOSYME DD1. The manufacturer is recalling a batch of the affected product as it does not comply with our quality expectations and may contain the gram negative bacteria, Sphingomonas Paucimobilis. The affected product is identified as follows:

• Packaging (Reference Number): 4x5L (1200036), 12X1L (1200095)
• Batch Number: B28123S

This bacteria Sphingomonas Paucimobilis is a known cause of infections in hospitalized patients. Patients, who have certain health problems like weakened immune systems, especially immunocompromised patients, or with chronic diseases, are at higher risk of infection.

According to the manufacturer, the affected product, ANIOSYME DD1, is a pre-disinfectant detergent for medico-surgical instrumentation and thermosensitive medical devices (endoscopy equipment)

1. For sterilizable equipment (autoclave or low temperature sterilization), the risk for patients is low, provided that the treatment steps of the devices are followed after the use of the affected product.
2. In the absence of sterilization, the risk for the patients is increased but remains globally low (case of the use of the affected product followed by a high level disinfection step)

The manufacturer has not identified any contamination in other batches of the affected product. As a measure of precaution, a restriction of use has been applied on other batches of the affected products (i.e. ANIOSYME DD1 and equivalents), which should only be used for the treatment of medical devices that will go through sterilization (i). Restriction will not be applied on the newly manufactured products.

The manufacturer is implementing corrective measures to eliminate the source of the contamination and putting in place additional hygiene safety protocols.

The customers are asked to take the following actions:

• To stop immediately using the recalled batch of the affected product that they may have in stock and to isolate them in order to destroy them or return back to the manufacturer.
• To limit the use of all the other batches of the affected products they might have in stock as of November 16 2019, to the treatment of medical devices that will go through a sterilization.

Product recall is on-going.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 12 December 2019