The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
AMSORB PLUS PREFILLED G-CAN 1.0L
Product Codes and Lot Numbers: See Recall Database Entry
Devices Recalled in the United States: 214,032
Distribution Date: October 22, 2020 to June 9, 2021
Date Initiated by Firm: August 5, 2021
AMSORB PLUS is a chemical substance used in anesthesia machines to absorb carbon dioxide (CO2) the patient breathes out while under anesthesia. This substance is provided in a prefilled canister (Prefilled G-CAN 1.0L) that is attached to the ventilator/anesthesia machine.
Reason for Recall
Armstrong Medical Limited is recalling this product due to reports that some AMSORB PLUS PREFILLED G-CAN 1.0L canisters have difficulties with gas flow that may cause a reduced flow of air to the patient. The difficulties in flow may cause a failure in the pre-use or “CHECK-OUT” test on the anesthesia machine. It may also occur when a patient is already under anesthesia if an affected canister is attached to the anesthesia machine while a patient is already under anesthesia.
If the flow issue is not addressed, this may prevent the ventilator from providing enough breathing assistance to the patient (hypoventilation), leading to a build-up of carbon dioxide in the patient’s body and causing negative health effects.
There have been no deaths or injuries reported for this recall.
Who May Be Affected
Health care providers using the AMSORB PLUS PREFILLED G-CAN 1.0L with their ventilator/anesthesia machines
Patients who are anesthetized with ventilator/anesthesia machines that use the AMSORB PLUS PREFILLED G-CAN 1.0L
What to Do
On August 5, 2021, Armstrong Medical Limited sent an urgent medical device correction letter to customers. The letter requested that nursing and medical staff (caregivers) working in anesthesia and critical care:
Review the list of devices that are potentially impacted by the recall.
Complete and return the customer response form to Armstrong Medical Limited or the distributor the device was received from to receive replacement units.
If users temporarily keep their stock of potentially affected devices, the company asks that they make sure a revised pre-use test is completed as a supplement to the existing “CHECK-OUT” test procedure, to make sure that the ventilator functions correctly:
Connect a 3L reservoir bag as a test lung to the patient breathing circuit connection.
Set the ventilator to VCV mode and the settings to TV to 500mL; RR to 60; I:E to 1:2; Tpause to Off; and Pmax to the highest setting.
Set the MV High alarm to Off.
Set the Fresh Gas flow to the minimum setting, then:
Start a case.
Set the Bag/Vent switch to Vent.
Fill the bellows using O2 flush.
Check that mechanical ventilation starts.
Check that the bellows inflate and deflate.
Check that the display shows the correct ventilator data.
Check that there are no inappropriate alarms. If inappropriate alarms occur, which may stem from canisters with high flow resistance, replace the CO2 absorbent canister and repeat this pre-use test.
Proceed to clinical use.
The company also advises:
Canisters should be replaced intraoperatively if unexpected, elevated gas flow resistance is observed or expected during clinical use, with or without associated anesthesia machine alarms.
During a procedure, fresh gas flow rate should be increased above the required minute ventilation volume until the end of the anesthesia procedure if an installed canister no longer adequately absorbs CO2 (due to absorbent exhaustion). The canister should then be replaced after the procedure is ended.
Contact Armstrong Medical Limited by emailing firstname.lastname@example.org or calling 00 44 (0)28 70356029 and asking for the Sales Department.
Medical Device Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.