FDA Class I Recalls: Convenience Kits by Avid Medical; Surgical Procedure Packs by DeRoyal Industries

June 28, 2021

The U.S. Food and Drug Administration announced that Avid Medical is recalling medical convenience kits that include the BD/Carefusion Chloraprep 3.0 mL applicator, due to the risk of contamination with a specific type of fungus called Aspergillus penicillioides, and DeRoyal is recalling the surgical procedure packs because the packs contain 1% lidocaine that has been mislabeled as 0.5% bupivacaine. 

Avid Medical

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. 

Avid Medical’s medical convenience kits include a set of devices that are used to complete routine medical and surgical care such as:

·        Draining fluid from an adult’s chest

·         Surgical repair of an abnormal connection between an artery and a vein (arteriovenous fistula)

·         Dressing changes around the surgical site of an arteriovenous fistula

·         Creating a dialysis access where a patient is connected to the dialysis machine

Each convenience kit listed above includes a Chloraprep 3.0 mL applicator, which is used to sanitize skin before surgery or catheter procedures. The Chloraprep 3.0 mL applicator is manufactured by another firm, BD/Carefusion 213. 

On April 9, 2021, Avid Medical sent an Urgent Notice of Field Action to all affected customers and provided the following instructions:

·         Immediately examine all inventory locations.

·         Discontinue use of kits 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 the company

FDA has the recall


Though both lidocaine and bupivacaine are local anesthetics, their dosing is different. If 1% lidocaine is given to the patient instead of 0.5% bupivacaine, the patient may be underdosed and experience pain during the procedure. If 0.5% bupivacaine is given to the patient instead of 1% lidocaine, it may cause an overdose of bupivacaine with potential life threatening or fatal consequences. 

This recall is related to a Hospira recall for the same mislabeling issue. DeRoyal Industries’ surgical procedure packs include a set of devices that are used for routine cardiac procedures such as heart catheterizations, pacemaker-related procedures and x-ray heart imaging (angiogram) procedures. Each pack includes Hospira Pfizer 1% lidocaine, a local anesthetic that prevents or reduces pain by stopping nerves from sending pain signals during a surgical or catheter procedure. 

On May 14, 2021, DeRoyal sent an Urgent Recall Notice to affected customers and provided the following instructions: 

•           Identify affected surgical packs and discontinue their use

•           Hold packs affected by this recall separately to ensure they are not used

•           Complete a form (provided with the recall notice) to inform the company of affected products on hand, even if no products are found in inventory, and return it

•           Return entire surgical packs to DeRoyal 

FDA has the recall