Ministry: Surgery prep applicator voluntarily recalled

The Ministry of Health says there has been a voluntary recall of one lot of ChloraPrep Clear 1 mL Applicator. These applicators are used for the preparation of a patient’s skin prior to surgery and helps reduce bacteria that can potentially cause skin infections.

In a release, the ministry said the recall, as stated in a release from BD (Becton, Dickinson and Co), is “due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.”

The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the healthcare professional and then consequently the sterile field.

Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death.

The affected lot of ChloraPrep Clear 1 mL Applicators can be identified by locating the referenced catalog number – 930480 and lot number – 3200240, on the lidding of the product package and on the side of the individual shelf box and shipper box.

BD’s release further stated, “This lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue”.

While the recalled products are not registered for use in TT, the ministry said, out of an abundance of caution it advises people who may be in possession of the identified lot of ChloraPrep Clear 1 mL Applicators to discontinue use immediately.

Additional information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division via email at [email protected] or phone at 217-4664 ext. 13101.

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