FDA Class I Recall

FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury

The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were found to contain injectable medications previously recalled by manufacturer Huons Co., Ltd.

The correction affects various Arrow surgical kits and procedure sets that include:

• 0.9% sodium chloride (10 mL saline) ampules
• Lidocaine ampules
• Bupivacaine ampules

The recall does not involve removing the convenience kits themselves from hospitals or healthcare facilities. Instead, healthcare providers are instructed to discard the affected injectable medications before using the kits and obtain replacement medications through their facility pharmacy.

Why the correction was issued

The affected injectable products were manufactured by Huons Co., Ltd., which previously initiated a recall involving the saline, lidocaine, and bupivacaine ampules.

According to FDA, using compromised injectable medications could lead to infection, inflammatory reactions, and reduced or absent anesthetic effect.

If lidocaine or bupivacaine fails to provide adequate anesthesia, patients could experience inadequate pain control, surgical complications, emergency conversion to alternative procedures, repeat or delayed procedures, and patient distress.

As of April 20, 2026, Arrow reported no serious injuries and no deaths associated with this issue.

What healthcare facilities should do

Arrow recommends that healthcare providers do not use the saline, lidocaine, or bupivacaine ampules supplied in affected kits, discard the affected ampules immediately when opening the kit, obtain replacement saline and anesthetic medications through the facility pharmacy, and inform all affected clinical personnel of the correction.

The remaining components of the convenience kits may continue to be used as intended once the affected injectable products have been removed.

Why it matters

This correction demonstrates how a quality issue involving a single component can affect multiple downstream medical products.

Although the convenience kits themselves are not defective, the inclusion of previously recalled injectable medications required corrective action because patient safety depends on every component of a procedural kit performing as intended.

FDA classified the action as a Class I recall, its most serious recall category, because compromised injectable medications used during surgical procedures could result in serious patient harm.

Links

Read the FDA’s announcement here.