IS CAN SPHERASORB C02 ABSORBENT CANISTER

Additional Manufacturer Narrative

EVALUATION SUMMARY: BASED ON THE PRODUCT COMPLAINT AND EVALUATION OF THE ABSORBER, THE PRODUCT IS BEING RECALLED. PRODUCT THAT WILL BE RECALLED WILL BE RELABELED WITH WARNINGS NOT TO USE ON THE GE-ADU AND ANMEDIC ANESTHESIA MACHINES. DURING SHIPPING IT WAS DISCOVERED THAT THE GRANULES WILL COMPRESS THE PAD AND ESCAPE INTO THE WATER TRAP AND POTENTIALLY INTO THE INSPIRATORY LIMB OF A BREATHING CIRCUIT. IS CANS TO BE MANUFACTURED WITH TWO FOAM PADS INSTEAD OF ONE IN THE BOTTOM OF THE CAN. A SCREEN WILL ALSO BE ADDED TO THE BOTTOM OF THE IS CAN BY THE WATER TRAP TO FURTHER PREVENT THE GRANULES FROM ESCAPING. THIS WILL ALLOW THE ABSORBER TO BE USED ON THE GE-ADU AND ANMEDIC ANESTHESIA MACHINES.

Description of Event or Problem

DURING THE PRE-USE CHECK OF THE ABSORBER ON THE ANESTHESIA MACHINE, IT WAS DISCOVERED THAT GRANULES WERE EXITING THE EXPIRATORY PORT ON THE ABSORBER AND ENTERING THE BREATHING CIRCUIT. THIS INCIDENT DID NOT OCCUR DURING PATIENT USE BUT THE RISK IS FOR THE PATIENT TO INHALE THE ABSORBENT GRANULES. THIS APPLIES ONLY TO THE GE-ADU AND ANMEDIC Q SYSTEMS ANESTHESIA MACHINES. THE FACILITY WHERE THIS OCCURRED IS USING A BREATHING FILTER IN THE BREATHING CIRCUIT THAT WOULD PREVENT THE GRANULES FROM BEING INHALED BY THE PATIENT.