Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0714-03

Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

GE Healthcare / initiated 2003-02-12 / Terminated

Datex-Ohmeda began a recall of Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers) on . The reason FDA records is "Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0714-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)
Product code
BSF Absorber, Carbon-Dioxide
Reason for recall
Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
FDA root cause
Other
Action
Recall letters dated February 12, 2003 requested that the product be removed from use and returned.
Quantity in commerce
5 S/5 Aespire Start-up kits
Distribution
Nationwide in the United States.
Product codes and lots
Lot numbers 728112 and 798122 of the Multi Absorbers in the kits