Z-0006-2008

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

Name: Z-0006-2008 GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia...
Creator: Datex - Ohmeda, Inc
Published: 2007-07-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-07-24 / Terminated / root cause: supplier

FDA source

Datex - Ohmeda, Inc began a recall of GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory... on 2007-07-24. The reason FDA records is "Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0006-2008
Status: Terminated
Initiated: 2007-07-24
Posted: 2007-10-04
Terminated: 2015-10-16
Recalling firm: GE Healthcare
Product: GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
Product code: BSF Absorber, Carbon-Dioxide
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: 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.
Quantity in commerce: 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, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: EZchange Manifold with part number 1407-7021-000, 1407-7027-000, M1053007, M1053008.

Product code BSF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)