FDA MedWatch - Medical Convenience Kits by Medical Action Industries:

Class I Recall - Due to Risk of Fungal (Aspergillus Penicillioides) Contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Medical Convenience Kits by Medical Action Industries: Class I Recall - Due to Risk of Fungal (Aspergillus Penicillioides) Contamination  AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Medical Action Industries is recalling the Medical Convenience Kits that include the BD/Carefusion Chloraprep 3 mL applicator. This component was recalled due to the risk of contamination with a specific type of fungus called Aspergillus penicillioides.  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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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 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.  RECOMMENDATIONS: On April 9, 2021, Medical Action Industries sent an Urgent Recall Notification to all affected customers and provided the following instructions:   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. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA