The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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
- 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.
Reason for Recall
Medical Action Industries’ is recalling the Medical Convenience Kits that include the BD/Carefusion Chloraprep™ 3mL 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.
Who May be Affected
- Health care providers using the Medical Action Industries convenience kits
- Patients who receive care using the Medical Action Industries convenience kits
What to Do
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.
Customers with questions about this recall should email Quality@owens-minor.com.
- Medical Device Recall Database Entry:
- 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
- FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)
- BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States (Parent firm for this recall)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.