FDA MedWatch – Medical Convenience Kits by Medical Action Industries:

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.

There have been no deaths, complaints, or reported injuries related to this issue.

• Dressing changes around a central line, a catheter in a large vein that delivers fluids and allows blood draws
• Injections
• Midline catheter insertion to deliver medications or fluids into a vein
• Dressing changes for left ventricular assist devices, a type of heart pump
• Collection of blood cultures to test for infections

Each convenience kit includes a Chloraprep 3 mL applicator, which is used to sanitize skin prior to wound care, catheter procedure or blood collection. The Chloraprep 3 mL applicator is manufactured by another firm, BD/Carefusion 213. 

• 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.