Medical Device
Manufacturing
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Z-2433-2019Class II

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

Getinge US Sales LLC / initiated 2019-07-22 / Terminated / root cause: labeling and UDI

GETINGE US SALES LLC began a recall of Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems on . FDA classified it as Class II and gives the reason as "Reversed expiration and manufacturing date on the label". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2433-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Getinge US Sales LLC
Product
Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
Product code
BSF Absorber, Carbon-Dioxide
Reason for recall
Reversed expiration and manufacturing date on the label
Root cause tag
labeling and UDI
FDA 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 in commerce
1444 boxes worldwide
Distribution
US nationwide distribution.
Product codes and lots
Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2433-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2433-2019Class IITerminatedVoluntary: Firm initiated