Recall Z-0006-2008
Datex - Ohmeda, Inc · initiated July 24, 2007
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.
Codes / lots: EZchange Manifold with part number 1407-7021-000, 1407-7027-000, M1053007, M1053008.
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.
FDA-determined cause: Vendor change control
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.
Details
- Recall number
- Z-0006-2008
- Initiated
- July 24, 2007
- Posted by FDA
- October 4, 2007
- Terminated
- October 16, 2015
- Product code
- BSF – Absorber, Carbon-Dioxide
- Quantity
- 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.
- Recalling firm
- Datex - Ohmeda, Inc, Madison, WI