FDA Medical Device Recalls (openFDA)
GETINGE US SALES LLC: Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
- Recall number
- Z-2433-2019
- Recalling firm
- GETINGE US SALES LLC
- Product
- Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
- Status
- Terminated
- Initiated
- 2019-07-22
- Posted
- not on file
- Terminated
- 2020-05-26
- Reason
- Reversed expiration and manufacturing date on the label
- Root cause
- Under Investigation by firm
- Action
- Firm issued letter 7/22/2019. 1. Examine your inventory immediately to determine if you have a FLOWi DISPOSABLE CO2 ABSORBER with the product lot numbers 2. Affected product should be returned to Getinge 3. Please complete the Urgent Medical Device Recall Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall Removal letter. 4. Please fax or email the completed form to Getinge office as instructed on the form. 5.Please contact Getinge Customer Service at 18886278383 (press option 2, then option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return authorization (RMA) and shipping instructions to return any affected product. If you have any questions, please contact Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Quantity
- 1444 boxes worldwide
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSF
- Firm FEI
- 3012092534
- Firm city
- WAYNE
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28