DeRoyal Issues Class I Recall of Surgical Procedure Packs

Brandon May

Disclosures

June 29, 2021

DeRoyal Industries has recalled its surgical procedure packs after the company found that the packs contain 1% lidocaine but were mislabeled as containing 0.5% bupivacaine. The US Food and Drug Administration (FDA) has declared the recall as class I, the most severe type of recall, which implies the packs carry a potential risk for serious injury or death.

Physicians who used the surgical procedure packs were notified of the recall in mid-May. To date, there have been no reported deaths, complaints, or injuries related to the surgical packs.

The DeRoyal surgical procedure packs contain a set of devices used for routine cardiac procedures. These devices are often used during heart catheterizations, pacemaker-related interventions, and angiograms.

This most recent DeRoyal recall is related to a Hospira recall, which concerned the same mislabeling problem.

Hospira Pfizer 1% lidocaine, a local anesthetic in each procedure pack, is used to prevent or reduce pain during a surgical intervention or catheter procedure. The problem is that the packs that contain 1% lidocaine have been mislabeled as 0.5% bupivacaine, another local anesthetic.

A statement on the recall notice explained that if a patient receives 1% lidocaine instead of 0.5% bupivacaine, there is a chance the patient will be underdosed and experience procedure-related pain. In contrast, administering 0.5% bupivacaine instead of 1% lidocaine may lead to a bupivacaine overdose, which increases the risk for life-threatening or fatal adverse events.

In the urgent recall notice that was sent to affected customers in May, DeRoyal told customers to try to identify affected packs and discontinue their use. Customers were also asked to separate all affected packs "to ensure they are not used."

Additionally, customers were instructed to complete a form that accompanied the notice in order to identify to DeRoyal the "affected products on hand, even if no products are found in inventory." All customers were asked to return the form and the products to the company.

Physicians and patients alike have been encouraged to report any adverse events or side effects associated with the packs to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

DeRoyal is no stranger to product recalls. Earlier this year, the company issued a recall of its cardiovascular basin procedure packs, citing problems with the sterility of the sternum saw blades within the packs. The FDA declared this recall as class II, meaning the use or exposure to the products could lead to temporary or "medically reversible" adverse health events.

Last year, DeRoyal issued a class II device recall of its sterile custom kits. These kits included BDPosiFlush syringes and were recalled because of holes in their packaging.

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