FDA Class I Recall: Medical Action Industries, Inc. 306 Medical Convenience Kits for risk of fungal contamination
The Food and Drug Administration (FDA) announced Medical Action Industries is recalling the Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with a specific type of fungus called Aspergillus penicillioides.
The FDA has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death. There have been no deaths, complaints, or reported injuries related to this issue.
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.
Recalled Product:
Medical Action Industries, Inc. 306 Medical Convenience Kits
Kit Models and Lot Numbers: Please see links below.
Distribution Dates: December 12, 2019 to March 22, 2021
Devices Recalled in the U.S.: 8,210
Date Initiated by Firm: April 9, 2021
Medical Action Industries’ Medical Convenience Kits include a set of devices that are used to complete routine medical care such as:
· 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 listed above 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.
