FDA Device Recall Z-0006-2008: Datex Ohmeda, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-2008.

Recall Res Number

Z-0006-2008

Recalling Firm / Manufacturer

Datex Ohmeda, Inc

FEI Number

2183066

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-07-24

Date Posted

2007-10-04

Date Terminated

2015-10-16

Product Code

BSF

Event Number

38484

Product Quantity

389,070

Product Description 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.

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 Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers EZchange Manifold with part number 1407-7021-000, 1407-7027-000, M1053007, M1053008.

Related Establishments / Registrations

INFINIUM MEDICAL, INC. Registration: 1066427 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
Datex-Ohmeda, Inc. Registration: 2112667 View Registration
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Registration: 2183066 View Registration
INTERSURGICAL LTD. Registration: 3002807267 View Registration
MOLECULAR PRODUCTS LTD Registration: 3002807637 View Registration
MOLECULAR PRODUCTS INC Registration: 3005367964 View Registration
GVS Technology (Suzhou) Co., Ltd Registration: 3005855942 View Registration
REITER-HG GEIGER KUNSTSTOFFTECHNIK GMBH Registration: 3009694883 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
SHANDONG JINLAI HUANHAI MEDICAL TECHNOLOGY CO.,LTD Registration: 3010187802 View Registration
Jiangsu Haize Medical Scientific Development Co.,Ltd. Registration: 3010601984 View Registration
SANICURE BV Registration: 3012494290 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
SAINT JONES MANAGEMENT LP EOOD Registration: 3016904853 View Registration
A-M Systems Registration: 3020614 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
HUZHOU JUNDA INDUSTRY CO., LTD. Registration: 3034669683 View Registration
BOEN HEALTHCARE CO., LTD. Registration: 3045058049 View Registration
MAQUET CRITICAL CARE AB Registration: 8010042 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
ARMSTRONG MEDICAL LTD. Registration: 9616692 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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Medical Device Recall: Z-0006-2008

Recall Parameters & Description

Related Establishments / Registrations

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