FDA DeviceClass INotable

FDA Recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANES

Date: 2026-06-24
Brand: ARROW INTERNATIONAL, LLC
Category: Medical Device
FDA Class: Class I

Description

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Hazard

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Remedy

79,614

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