A medical care kit company is recalling more than 8,200 kits because they contain BD applicators that may become contaminated with a fungus.
The recall by Medical Action Industries covers certain of its 306 Medical Convenience Kits, distributed between December 12, 2019, and March 22, 2021, according to the FDA. The agency has labeled the recall Class I, the most serious type.
Mechanicsville, Va.-based Medical Action Industries, which is owned by Owens & Minor, initiated the recall last month. It follows BD’s own expanded recall of its ChloraPrep 3 mL applicator, which is used to sanitize skin prior to wound care, catheter procedure or blood collection.
BD previously said that storage of the ChloraPrep 3 mL applicator in regions of the world with high heat and humidity may expose the product to temperatures of 30°C (86°F) and 75% relative humidity, allowing the growth of Aspergillus penicillioides. Growth of the fungus within the packaging can contaminate the applicator’s surface and/or the gloved hands of the healthcare professional using it. Then it can contaminate the sterile field. Because the applicator is used to prepare a site before an invasive procedure, contamination can result in direct inoculation of the fungus to tissues.
If skin preparation products are contaminated with Aspergillus penicillioides, the fungus can cause serious systemic infection, sepsis, illness, and death to the patient. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter may need to be removed, requiring additional medical procedures. If the fungus infects a surgical site, the patient may require medical and surgical treatments and require long-term treatment with antifungal drugs, according to the FDA.
No complaints, adverse events, injuries or deaths have been reported related to the recall, the agency said. BD previously said that its own recall does not include 3 ml applicators found in kits or any other ChloraPrep product presentations, as all other ChloraPrep products are manufactured with different packaging materials unaffected by the issue.
BD also said it is implementing a global packaging change for the 3 mL product to correct the issue.
Medical Action Industries sent its recall notification to all affected customers, advising them to:
- Immediately examine all inventory locations.
- Discontinue use of Medical Action trays affected by this recall.
- Discard any inventory on hand in accordance with facility standard procedures.
- Report responses received from customers/end-users of the product and quantities destroyed to Quality@owens-minor.com.
The company listed the affected products as:
- Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420.
- Kit: Blood Culture. MAI Kit Part Number: 80315D.
- Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B.
- Kit: Midline Insertion DA. MAI Kit Part Number: 77981B.
- Kit: Injection REVIEW MAI Kit Part Number: 74736.
- Kit: Blood Culture MAI Kit Part Number: 80076.