Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert

Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices.

The FDA has classified this correction as the most serious type because continued use of the lidocaine could cause serious injury or death. The correction does not require removal of the kits from the market, but users must remove the lidocaine component before further use.

The notice lists the affected product numbers, lot and batch numbers, covering various introducer trays, pacing electrode trays, arterial line kits, bone marrow trays and biopsy trays. Customers are instructed to check their inventory and not use the lidocaine ampules in those kits.

Argon Medical recommends correcting the kits by removing the lidocaine ampules immediately and following any additional FDA guidance.