WASHINGTON (dpa-AFX) - Medical technology company Becton, Dickinson and Co. or BD has recalled one lot of ChloraPrep Clear 1 mL Applicators citing potential fungal contamination, the U.S. Food and Drug Administration said. Under certain environmental conditions, the contamination allows the growth of Aspergillus penicillioides within the packaging.
The product is used for the preparation of the patient's skin prior to surgery, aiming to reduce bacteria that potentially can cause skin infection.
The impacted product is packaged in a pouch, i.e., 1 applicator per pouch, 60 applicators per inner carton, and 4 Inner Cartons per Case. The affected lot of 3200240 with Product NDC 54365-400-31 and Expiry Date 6/30/2026 was distributed globally beginning in September 2023.
The agency noted that Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional. This would consequently contaminate the sterile field.
As the applicator is used for site preparation prior to an invasive procedure, if contaminated, it can cause 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.
However, there have been no reported customer complaints or adverse events associated with the issue so far.
Aspergillus penicillioides infection of a surgical site mostly will require medical and surgical interventions and long-term treatment with antifungal drugs.
The agency urged for immediate discontinuation of the use of the affected lot, and to destroy all affected units in the inventory. If destruction is not immediately possible, then the impacted product is required to be quarantined until disposal.
In similar recalls due to fungal contamination, Fort Worth, Texas-based Alcon Laboratories, affiliated to Swiss eye care device firm Alcon Inc., in December called back one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count.
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