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Terminated

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

FDA Recall Z-2433-2019 · Posted None

Recalling FirmGETINGE US SALES LLC
Recall StatusTerminated
Product CodeBSF
Date Initiated2019-07-22
Date Terminated2020-05-26
Product Quantity1444 boxes worldwide

Reason for Recall

Reversed expiration and manufacturing date on the label

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).

Root Cause

Under Investigation by firm

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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