GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The E

FDA device recall Z-0006-2008 · posted 2007-10-04 · Terminated

Recall details

Recalling firm

Datex - Ohmeda, Inc

Reason for recall

Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.

Action taken

Because this issue only occurs when the Disposable Multi Absorber is used in conjunction with EZchange Module, they have contacted all EZchange Module customers. It is critical to contact these customers specifically, rather than all customers shipped Disposable Multi Absorbers as this may cause unwarranted confusion with customers who do not have the EZchange Module. Consignees were sent an letter dated 7/19/2007 describing the product and problem. The letter lists a number of interim actions to implement with the anesthesia systems.

Root cause

Vendor change control

Status

Terminated

Product code

BSF

Quantity affected

389,070

Distribution

Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherl

Date initiated

2007-07-24

Date posted

2007-10-04

Date terminated

2015-10-16

Location

Madison, WI