FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chloride ampules that were part of a separate recall by Huons Co., Ltd.
Medical Action has sent a letter to customers advising that the affected kits be corrected before further use. The correction involves removing the recalled sodium chloride ampules from the kits.
The alert lists multiple kit models and lot numbers that are impacted, covering both epidural/pain trays and single‑shot epidural kits. Users are instructed not to use the sodium chloride ampules in these kits and to verify the kits against the provided lot numbers.
The FDA will continue to monitor the situation and update the public page as new information becomes available.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Epidural Kit Issue from Medical Action Industries”
read at fda medwatch ↗
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