The Recall Desk
HighFDA (Devices)·Z-1443-2013·Announced 2013-06-12

GE Healthcare Recalls CO2 Absorbent Canisters for Anesthesia Systems

GE Healthcare is recalling 800 reusable CO2 absorbent canisters used with anesthesia systems because they may not seal properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for anesthesia and ventilatory support where a sealing defect poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 800 reusable CO2 absorbent canisters used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, and 9300 anesthesia systems. The canisters, identified by GE part numbers 1407-3200-000, 1407-7004-000, or M1084850, are intended to provide general inhalation anesthesia and ventilatory support.

The recall was initiated because the reusable CO2 absorbent canisters may not seal properly. This potential safety issue affects canisters with a date code of 02-2013 (Feb 2013).

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Asia, Europe, the Americas, and the Middle East. Users should stop using the affected canisters and contact GE Healthcare for further instructions.

The recalled product

Product
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Manufacturer
GE Healthcare, LLC
Affected units
800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Canisters with date code of 02-2013 (Feb 2013)

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically: